Coronary Dilatation Catheter - India CDSCO Medical Device Registration

Coronary Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000018_fd4b8ea69c6295bd33f104c4d506ff3d_e057b88528a761c81adc2ee0db63ae30. This device is marketed under the brand name Trek RX Coronary Dilatation Catheter ,Trek OTW Coronary Dilatation Catheter , NC Trek RX Coronary Dilatation Catheter. 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

Coronary Dilatation Catheter

UID: IMP/MD/2020/000018_fd4b8ea69c6295bd33f104c4d506ff3d_e057b88528a761c81adc2ee0db63ae30

Brand Name

Trek RX Coronary Dilatation Catheter ,Trek OTW Coronary Dilatation Catheter , NC Trek RX Coronary Dilatation Catheter

License Holder

Abbott Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Mini Trek RX and Mini Trek II OTW Coronary Dilatation Catheter is indicated for: • Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion • Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction (Trek RX Coronary Dilatation Catheter ,Trek OTW Coronary Dilatation Catheter , NC Trek RX Coronary Dilatation Catheter) • Balloon dilatation of a stent after implantation (Trek RX Coronary Dilatation Catheter ,Trek OTW Coronary Dilatation Catheter , NC Trek RX Coronary Dilatation Catheter) • Balloon dilatation of de novo chronic total coronary occlusions (Trek RX Coronary Dilatation Catheter ,Trek OTW Coronary Dilatation Catheter , NC Trek RX Coronary Dilatation Catheter)

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Coronary Dilatation Catheter

Brand: Ultraskin

M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,

Class D

Coronary Dilatation Catheter

Brand: Sapphire II NC

Innvolution Healthcare Pvt. Ltd.,

Class D

Coronary Dilatation Catheter

Brand: Sapphire II NC

Innvolution Healthcare Pvt. Ltd.,

Class D

Coronary Dilatation Catheter

Brand: Sapphire 3

Innvolution Healthcare Pvt. Ltd.,

Class D

Coronary Dilatation Catheter

Brand: Sapphire 3

Innvolution Healthcare Pvt. Ltd.,

Class D

Coronary Dilatation Catheter

Brand: Trek RX Coronary Dilatation Catheter ,Trek OTW Coronary Dilatation Catheter , NC Trek RX Coronary Dilatation Catheter

Abbott Healthcare Private Limited

Class C

Coronary Dilatation Catheter

Brand: Lacrosse NSE ALPHA Coronary Dilatation Catheter

NIPRO MEDICAL (INDIA) PRIVATE LIMITED ,2ND FLOOR, GMR AERO TOWERS, NEAR RAJIV GANDHI AIRPORT, MAMIDIPALLY VILLAGE, BALAPUR MANDAL, RANGA REDDY DIST, MAMIDPALLY(V), BALAPUR(M), RANGA REDDY(DIST.) ,Ranga Reddy Telangana ,500108 ,India

Class C