Polytetrafluoroethylene Intra-cardiac patch - India CDSCO Medical Device Registration

Polytetrafluoroethylene Intra-cardiac patch is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000230_c14617106143bda64a052506104527c3_352588a98a8e9c4ed932c47f650c7a6f. This device is marketed under the brand name Bylatoral Femoral Bypass Surgery Kit. The license holder is Lotus Surgical Pvt Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class D

Polytetrafluoroethylene Intra-cardiac patch

UID: MFG/MD/2019/000230_c14617106143bda64a052506104527c3_352588a98a8e9c4ed932c47f650c7a6f

Brand Name

Bylatoral Femoral Bypass Surgery Kit

License Holder

Lotus Surgical Pvt Ltd

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

PTFE Pledgets used in various applications for general, vascular and cardiac surgery. Pledgets are used as buttresses under sutures when there is a possibility of sutures tearing through tissue. PTFE Pledgets are indicated for the purposes of tissue approximation, retraction, and as a temporary or permanent ligature