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510(k) K032632

REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH by Estech, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2003
Date Received
August 26, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Estech, Inc.

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  • K053021 — ESTECH CLEARVIEW MV ATRIAL DEPRESSOR (January 26, 2006)
  • K052081 — REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA (December 16, 2005)
  • K051749 — COBRA SURGICAL SYSTEM (September 13, 2005)
  • K041599 — COBRA ADHERE SURGICAL SYSTEM (July 27, 2004)
  • K990573 — ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA (March 11, 1999)

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