Singapore HSA registration DE0504473
Angeion Medical Tri-Wedge PTA Scoring Balloon Dilatation Catheter
Singapore·CLASS B·Angeion Medical International Pte Ltd·Registered May 13, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0504473
- Registration Date
- May 13, 2020
- Change Notification Approval Date
- July 16, 2020
- Retention Due Date
- May 12, 2025
Product description
The balloon dilatation catheter is indicated to dilate stenoses in the femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product Owner
- Short Name
- Angeion Medical International Pte Ltd
- Address
- 114 LAVENDER STREET, CT HUB 2, #03-61, SINGAPORE 338729
Registrant
- Address
- 100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Importer
- Address
- 100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Model information
- Model Name(s)
- Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x20mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x30mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x40mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x60mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x20mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x30mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x40mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x60mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x20mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x30mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x40mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x60mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x20mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x30mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x40mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x60mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x20mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x30mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x40mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x60mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x20mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x30mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x40mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x60mm, 90cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x20mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x30mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x40mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x60mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x20mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x30mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x40mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x60mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x20mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x30mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x40mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x60mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x20mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x30mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x40mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x60mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x20mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x30mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x40mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x60mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x20mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x30mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x40mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x60mm, 75cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x60mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x20mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x30mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x40mm, 50cm Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x60mm, 50cm
- Model Identifier(s)
- 21-18L32 21-18L33 21-18L34 21-18L36 21-18L42 21-18L43 21-18L44 21-18L46 21-18L52 21-18L53 21-18L54 21-18L56 21-18L62 21-18L63 21-18L64 21-18L66 21-18L72 21-18L73 21-18L74 21-18L76 21-18L82 21-18L83 21-18L84 21-18L86 21-18S32 21-18S33 21-18S34 21-18S36 21-18S42 21-18S43 21-18S44 21-18S46 21-18S52 21-18S53 21-18S54 21-18S56 21-18S62 21-18S63 21-18S64 21-18S66 21-18S72 21-18S73 21-18S74 21-18S76 21-18S82 21-18S83 21-18S84 21-18S86 21-35L32 21-35L33 21-35L34 21-35L36 21-35L42 21-35L43 21-35L44 21-35L46 21-35L52 21-35L53 21-35L54 21-35L56 21-35L62 21-35L63 21-35L64 21-35L66 21-35L72 21-35L73 21-35L74 21-35L76 21-35L82 21-35L83 21-35L84 21-35L86 21-35S32 21-35S33 21-35S34 21-35S36 21-35S42 21-35S43 21-35S44 21-35S46 21-35S52 21-35S53 21-35S54 21-35S56 21-35S62 21-35S63 21-35S64 21-35S66 21-35S72 21-35S73 21-35S74 21-35S76 21-35S82 21-35S83 21-35S84 21-35S86
About this record
Access comprehensive regulatory information for Angeion Medical Tri-Wedge PTA Scoring Balloon Dilatation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504473 and owned by Angeion Medical International Pte Ltd. The device was registered on May 13, 2020.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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