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510(k) K872167

CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 by American Bentley — Product Code DTP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1987
Date Received
June 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Defoamer, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4230
Review Panel
CV
Submission Type

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  • 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)
  • K860673 — OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B (June 26, 1986)

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