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/2019/000511_ea356a175d3162e483db0a26945a5fdc_759ba7ac679a04efde490e41f9940002. This device is marketed under the brand name Perclose ProGlide. The license holder is Abbott Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Suture-Mediated Closure System

UID: IMP/MD/2019/000511_ea356a175d3162e483db0a26945a5fdc_759ba7ac679a04efde490e41f9940002

Brand Name

Perclose ProGlide

License Holder

Abbott Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Perclose ProGlide SMC System is indicated for percutaneous delivery of suture for closing the common femoral artery and vein access site to 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 required. • For the 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