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510(k) K792152

CARDIOPLEGIA SOLUTION ADMIN. SET by Cardio Systems, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
October 22, 1979
Clearance Type
Traditional
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

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  • K972022 — ZAK-2000 (January 22, 1998)
  • K934689 — LOW AIR LOSS MATTRESS, MODIFICATION (February 2, 1994)
  • K921500 — CENTRI-SAFE(TM) VALVE (September 15, 1992)
  • K882177 — ADD-ON TO CRITICAL PATIENT CARE BED (December 1, 1988)
  • K852736 — BAYLOR RAPID AUTOTRANSFUSION SYSTEM (September 18, 1985)
  • K792151 — OXYGENATOR GAS LINE FILTER (November 13, 1979)

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