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510(k) K862549

ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE by American Bentley — Product Code KRI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1986
Date Received
July 3, 1986
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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  • K872133 — OXYGENATOR MODEL NO. BENTLEY 5 PLUS (August 24, 1987)
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  • K870269 — ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 (March 9, 1987)
  • K863249 — OXYGENATOR MODEL NO. BENTLEY-10 PLUS (October 20, 1986)
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  • K860673 — OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B (June 26, 1986)

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