Pure Global

Coronary Stent - Aortic Stent-Self Expandable Nitinol Stent (mc-a Aortic Stent- Self Expandable Nitinol Stent ) - India CDSCO Medical Device Registration

Coronary Stent - Aortic Stent-Self Expandable Nitinol Stent (mc-a Aortic Stent- Self Expandable Nitinol Stent ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000200_2d8a43063e3fc7da831f0cc0cfcc3fb2_34269f2fe6d44c37e50533da65e085bf. This device is marketed under the brand name Sterile. The license holder is Vascular Concepts Limited, and it is classified as Device Class Class D. 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 D
Coronary Stent - Aortic Stent-Self Expandable Nitinol Stent (mc-a Aortic Stent- Self Expandable Nitinol Stent )
UID: IMP/MD/2020/000200_2d8a43063e3fc7da831f0cc0cfcc3fb2_34269f2fe6d44c37e50533da65e085bf

Brand Name

Sterile

Device Class

Class D

Approving Authority

CDSCO

Product Information

The mc-a is indicated for the treatment of dissections, stenoses and other specific lesions of the thoracic descending aorta, the abdominal aorta as well as for treatment of vena-cava syndrome. In any case the anatomical dimensions must match the available stent sizes. For this reason its application is restricted to adults only. Indications for the usage of the mc-a can be regarded as existent in the following cases: -Dissections (Sterile) -Aortic coarctations -Arteriosclerotic aortic stenoses -Insufficient angioplasty results -Elastic stenoses from bypass anastomoses -Endoleaks of type 1a and 1b (Sterile). -obstructions or upper and lower inflow congestion of the vena cava due to malignant or benign causes (Sterile) Places of indication: -In the aorta abdominalis, in the straight area of the aorta thoracalis descendants as well as in the aortic arch distal to the exit of the left arteria subclavia -In the vena-cava in case of upper and lower venous congestion.

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing