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510(k) K882892

MEMBRANE OXYGENATOR by Baxter Bentley Laboratories, Inc. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1988
Date Received
July 11, 1988
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 Baxter Bentley Laboratories, Inc.

  • K905311 — DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. (January 15, 1991)
  • K905312 — DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS (January 15, 1991)

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