Suture-Mediated Closure System - India CDSCO Medical Device Registration

Suture-Mediated Closure System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000509_ea356a175d3162e483db0a26945a5fdc_af466226f74c707e4f31d1a8547edde6. This device is marketed under the brand name NC TREK NEO™. The license holder is Abbott Healthcare Private Limited, and it is classified as Device Class Class C. 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 C

Suture-Mediated Closure System

UID: IMP/MD/2023/000509_ea356a175d3162e483db0a26945a5fdc_af466226f74c707e4f31d1a8547edde6

Brand Name

NC TREK NEO™

License Holder

Abbott Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Perclose ProGlide™ SMC System 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.