Singapore HSA registration DE0509733
Abbott Medical Perclose ProStyle Suture-Mediated Closure and Repair System
Singapore·CLASS C·Abbott Medical·Registered September 05, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0509733
- Registration Date
- September 05, 2024
- Retention Due Date
- September 04, 2025
Product description
The Perclose ProStyle SMCR System is intended to restore normal blood vessel hemostasis. It is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures: • For access sites in the common femoral artery using 5F to 21F sheaths. For sheath sizes greater than 8F, at least two devices and the pre-close technique are required. • For access sites in the common femoral vein using 5F to 24F sheaths. For sheath sizes greater than 8F, at least one device and the pre-close technique is required.
Product Owner
- Name
- Abbott Medical
- Short Name
- Abbott Medical
- Address
- 3200 Lakeside Drive, Santa Clara, CA 95054, UNITED STATES
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
- Model Name(s)
- Perclose ProStyle Suture-Mediated Closure and Repair System
- Model Identifier(s)
- 12773-02
About this record
Access comprehensive regulatory information for Abbott Medical Perclose ProStyle Suture-Mediated Closure and Repair System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509733 and owned by Abbott Medical. The device was registered on September 05, 2024.
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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