Pure Global

Peripheral Stent - India CDSCO Medical Device Registration

Peripheral Stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000188_e3072ffee1f6efc4bb60602fe90d1010_c4aaabd8de4aa97c89c00a0e66f0c968. This device is marketed under the brand name PALMAZ™. The license holder is Cardinal Health Medical Products India Pvt Ltd, 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
Powered by Pure Global AI
CDSCO Registered
Class Class C
Peripheral Stent
UID: IMP/MD/2022/000188_e3072ffee1f6efc4bb60602fe90d1010_c4aaabd8de4aa97c89c00a0e66f0c968

Brand Name

PALMAZ™

Device Class

Class C

Approving Authority

CDSCO

Product Information

The PALMAZ balloon-expandable Stent is indicated for use in peripheral vessels below the aortic arch in patients who are acceptable candidates for percutaneous transluminal angioplasty. The lumen diameter of all vessels between the entry site and the lesion site must be large enough to accept a 12F or 13F introducer sheath. If the vessels are not large enough due to a lesion, an angioplasty procedure must be performed to produce a lumen of sufficient size. The target vessel must be large enough to accommodate the stent expanded to 15mm. In order to perform a successful stent implantation, a CT scan is recommended to ensure the accurate measurement of the passage vessels and the target vessel.

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Similar Products (1)
Other products with the same name or brand

Peripheral Stent

Brand: Andrastent

Globe Bio Medicals

Class C
Other Products from Cardinal Health Medical Products India Pvt Ltd
Products from the same license holder (10 products)

Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

Brand: PTA

Class C

Guidewire

Brand: SV

Class D

Steerable Guidewires

Brand: SV

Class D

Steerable Guidewires

Brand: SV

Class D

Steerable Guidewires

Brand: SV

Class D

Steerable Guidewires

Brand: SV

Class D

Foam Electrodes

Brand: Kendall

Class B

Sheathless Access System

Brand: RAILWAY™

Class B

Nitinol Stent System

Brand: VISTA BRITE TIP

Class D

Guiding Catheter

Brand: VISTA BRITE TIP

Class D