Intra-vascular Balloon Catheter - India CDSCO Medical Device Registration

Intra-vascular Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000111_c6d90f05cb37b9e16be0e9d035255946_d2eb03cc77c5e522fdb9912fc138280f. This device is marketed under the brand name OptiSite Arterial Perfusion Cannula. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class D. The approving authority is CDSCO.

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.

Free Database

CDSCO Registered

Class Class D

Intra-vascular Balloon Catheter

UID: IMP/MD/2018/000111_c6d90f05cb37b9e16be0e9d035255946_d2eb03cc77c5e522fdb9912fc138280f

Brand Name

OptiSite Arterial Perfusion Cannula

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

Retrograde Coronary Sinus Cardioplegia Catheters with and without Duraflo treatment are intended for delivery of blood or cardioplegia solution intraoperatively to avoid cardiac damage and aid in myocardial protection. Extracorporeal circuit components with a Duraflo treatment are intended for use in cardiopulmonary bypass when a heparin treated catheter is desired upon initial placement.