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510(k) K854113

CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH by American Bentley — Product Code KRI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1986
Date Received
October 8, 1985
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

Other clearances by American Bentley

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  • K873923 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (November 6, 1987)
  • K870804 — CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 (September 1, 1987)
  • K872167 — CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 (September 1, 1987)
  • K872133 — OXYGENATOR MODEL NO. BENTLEY 5 PLUS (August 24, 1987)
  • K870911 — INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY (May 29, 1987)
  • K870269 — ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 (March 9, 1987)
  • K863249 — OXYGENATOR MODEL NO. BENTLEY-10 PLUS (October 20, 1986)
  • K861641 — HEPARIN-COATED EXTRACORPOREAL CIRCUITS (September 29, 1986)
  • K862549 — ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE (July 15, 1986)

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  • K884893 — CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (January 30, 1989)
  • K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (January 24, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)