CDSCO UID MFG/MD/2019/000008_23c041eab041a9dcfc0f82f07b5befd3_0b032c8008d7f490ac93654addbe6b8f

Pre-Dilatation Balloon Catheter

PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: X-Change Aspiration Catheter
Registration details
UID
MFG/MD/2019/000008_23c041eab041a9dcfc0f82f07b5befd3_0b032c8008d7f490ac93654addbe6b8f
Device class
Class C
Brand name
X-Change Aspiration Catheter
Approving authority
Central Drug Standards Control Organization, Ahmedabad
Product information
The PTCA Pre Dilatation Catheter is intended for use in patients with clinical symptoms of myocardial ischemia related to the pathological condition of one or more coronary arteries and who are regarded as being candidates for myocardial revascularization. Dilatation of Stenotic portion of Coronary artery
Similar products (3)
Other products with the same name or brand
CTO PTCA Pre-Dilatation Balloon Catheter
Brand: X-Change Aspiration Catheter
PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED
Class C
Aspiration Catheter
Brand: X-Change Aspiration Catheter
PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED
Class C
NC PTCA Post Dilatation Balloon Catheter
Brand: X-Change Aspiration Catheter
PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED
Class C
Other products from PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED
Products from the same license holder (10 products)
CTO PTCA Pre-Dilatation Balloon Catheter
Brand: X-Change Aspiration Catheter
Class C
Biodegradable Polymer based Sirolimus Eluting Coronary Stent System
Brand: Vestasync Sirolimus Eluting Coronary Stent System
Class D
Biodegradable Polymer based Everolimus Eluting Coronary Stent System
Brand: Vestasync Sirolimus Eluting Coronary Stent System
Class D
Stainless Steel coronary stent system
Brand: Vestasync Sirolimus Eluting Coronary Stent System
Class D
Cobalt Chromium coronary stent system
Brand: Vestasync Sirolimus Eluting Coronary Stent System
Class D
Aspiration Catheter
Brand: X-Change Aspiration Catheter
Class C
Polymer free Hydroxyapatite coated Sirolimus Eluting Coronary Stent System
Brand: Vestasync Sirolimus Eluting Coronary Stent System
Class D
Hydroxyapatite Cobalt Chromium coronary stent system
Brand: Vestasync Sirolimus Eluting Coronary Stent System
Class D
Rapamycin Target Eluting Coronary Stent System
Brand: Vestasync Sirolimus Eluting Coronary Stent System
Class D
NC PTCA Post Dilatation Balloon Catheter
Brand: X-Change Aspiration Catheter
Class C
About this record

Pre-Dilatation Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000008_23c041eab041a9dcfc0f82f07b5befd3_0b032c8008d7f490ac93654addbe6b8f. This device is marketed under the brand name X-Change Aspiration Catheter. The license holder is PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.