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510(k) K905312

DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS by Baxter Bentley Laboratories, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1991
Date Received
November 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Baxter Bentley Laboratories, Inc.

  • K905311 — DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. (January 15, 1991)
  • K882892 — MEMBRANE OXYGENATOR (September 27, 1988)

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