Balloon Dilatation Catheter - India CDSCO Medical Device Registration

Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000050_16eb53f14e746dc332d80db12a830d7a_c366e4f789162d6687b4c6952f2970be. This device is marketed under the brand name Scoreflex PTA. The license holder is Innvolution Healthcare Pvt. Ltd.,, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Balloon Dilatation Catheter

UID: IMP/MD/2020/000050_16eb53f14e746dc332d80db12a830d7a_c366e4f789162d6687b4c6952f2970be

Brand Name

Scoreflex PTA

License Holder

Innvolution Healthcare Pvt. Ltd.,

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Scoreflex PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including fistula / shunt, iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae