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510(k) K000977

COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS by Olson Medical Sales, Inc. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2001
Date Received
March 27, 2000
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 Olson Medical Sales, Inc.

  • K993060 — GAS FILTER (March 28, 2000)
  • K993062 — CHEST DRAINAGE TUBING (December 10, 1999)
  • K992906 — COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT (November 10, 1999)

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  • K212688 — Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exc (January 10, 2022)
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