Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter - India CDSCO Medical Device Registration

Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000149_f38a95670092cb334e9bffcd87e3baef_097dac169504bf450848a2ba2cb931c1. This device is marketed under the brand name PTA. The license holder is Cardinal Health Medical Products India 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

Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

UID: IMP/MD/2022/000149_f38a95670092cb334e9bffcd87e3baef_097dac169504bf450848a2ba2cb931c1

Brand Name

PTA

License Holder

Cardinal Health Medical Products India Pvt Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The POWERFLEX® PRO PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Class B

Percutaneous Transluminal Angioplasty Catheter

Brand: PTA

Abbott Healthcare Private Limited

Class B

Brand: VISTA BRITE TIP

Class D