Occluder(Cocoon PFO Occluder ) - India CDSCO Medical Device Registration

Occluder(Cocoon PFO Occluder ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000188_49a4c5e5c45bfe390b92d662c3baebdd_f3f735ad036edd30385dc76f6c3ede40. 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.

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CDSCO Registered

Class Class D

Occluder(Cocoon PFO Occluder )

UID: IMP/MD/2020/000188_49a4c5e5c45bfe390b92d662c3baebdd_f3f735ad036edd30385dc76f6c3ede40

Brand Name

Sterile

License Holder

Vascular Concepts Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Cocoon PFO Occluder is a percutaneous, transcatheter closure device intended for the occlusion of normal and aneurysm type PFOs, in patients with a history of stroke or Transient Ischemic Attack, as diagnosed by echo-cardiography with right-to-left shunting during Valsalva maneuver.

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