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510(k) K905311

DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. by Baxter Bentley Laboratories, Inc. — Product Code DWD

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
Suction Control, Intracardiac, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4430
Review Panel
CV
Submission Type

Other clearances by Baxter Bentley Laboratories, Inc.

  • K905312 — DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS (January 15, 1991)
  • K882892 — MEMBRANE OXYGENATOR (September 27, 1988)

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  • K895427 — MEDISEAL SUCTION CANISTER (January 19, 1990)
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  • K863593 — SARNS SAFETY LOOP (November 18, 1986)
  • K862540 — LEFT VENTRICULAR VENT VALVE MODEL NO. GLV (August 29, 1986)
  • K861428 — SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 (June 26, 1986)