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510(k) K931967

HE-30 GOLD by Bentley Laboratories, Inc. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1993
Date Received
April 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat-Exchanger, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4240
Review Panel
CV
Submission Type

Other clearances by Bentley Laboratories, Inc.

  • K913956 — BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 (January 17, 1992)
  • K913692 — VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) (November 15, 1991)
  • K903641 — QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q (November 9, 1990)
  • K894826 — UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF (February 28, 1990)
  • K874867 — CATR(TM)-H CARDIOTOMY HOLDER (February 2, 1988)
  • K874841 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (February 2, 1988)
  • K874618 — BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER (January 19, 1988)
  • K823359 — OXYGEN CONSUMPTION MONITOR #OCM-0100 (January 5, 1983)
  • K823273 — BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. (January 5, 1983)
  • K823456 — OXYGENATORS #BOS-10, 105, 5S (December 30, 1982)

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