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510(k) K905311

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

K905311 is an FDA 510(k) premarket notification submitted by Baxter Bentley Laboratories, Inc. for the device "DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.". The FDA issued a decision of Substantially Equivalent on January 15, 1991. The device falls under product code DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4430. Baxter Bentley Laboratories, Inc. has at least 2 other 510(k) clearances on record.

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)

Other clearances for product code DWD

  • K992657 — IBC VRV, MODEL 1350 (February 18, 2000)
  • K920077 — NIKKISO NK PUMP (September 29, 1993)
  • K915482 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT (January 7, 1992)
  • K915480 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. (January 7, 1992)
  • K915481 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT (January 7, 1992)
  • K895427 — MEDISEAL SUCTION CANISTER (January 19, 1990)
  • K864503 — MODIFIED RLV-2100 B (January 6, 1987)
  • 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)

FDA data resources