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510(k) K861641

HEPARIN-COATED EXTRACORPOREAL CIRCUITS by American Bentley — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
April 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

Other clearances by American Bentley

  • K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 (February 12, 1988)
  • K873923 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (November 6, 1987)
  • K872167 — CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 (September 1, 1987)
  • K870804 — CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 (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)
  • K862549 — ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE (July 15, 1986)
  • K860673 — OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B (June 26, 1986)

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