Thrombectomy Catheter - India CDSCO Medical Device Registration

Thrombectomy Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000344_51c277d2f710e3bedc677f3699edb434_32b4cb358cac1de3f2c99818df310ee2. This device is marketed under the brand name Swan-Ganz CCO, Swan-Ganz CCO V, Swan-Ganz CCOmbo, Swan-Ganz CCOmbo V Thermodilution Catheters. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Thrombectomy Catheter

UID: IMP/MD/2018/000344_51c277d2f710e3bedc677f3699edb434_32b4cb358cac1de3f2c99818df310ee2

Brand Name

Swan-Ganz CCO, Swan-Ganz CCO V, Swan-Ganz CCOmbo, Swan-Ganz CCOmbo V Thermodilution Catheters

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

Intended Use - The Fogarty Graft Thrombectomy catheter is designed to remove organized thrombus and adherent thrombotic material from synthetic bypass grafts, specifically AV fistulas for dialysis access and grafts for iliofemoral bypass. The Fogarty Graft Thrombectomy Catheters are indicated for the following: 1. General indications for arterial reconstruction of an obstructed graft include disabling claudication, ischemic pain at rest, ischemic skin lesions, or gangrene. 2. General indications for reconstruction of a synthetic AV fistula internal bridge graft include the inability to properly dialyze the patient