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510(k) K792151

OXYGENATOR GAS LINE FILTER by Cardio Systems, Inc. — Product Code KRI

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
Accessory Equipment, Cardiopulmonary Bypass
Device Class
Class I
Regulation Number
870.4200
Review Panel
CV
Submission Type

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  • K792152 — CARDIOPLEGIA SOLUTION ADMIN. SET (November 13, 1979)

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  • K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (January 24, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)