DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.— 510(k) K905311

Name: FDA 510(k) clearance K905311
Creator: U.S. Food and Drug Administration
Published: 1991-01-15

Substantially Equivalent

Baxter Bentley Laboratories, Inc.

FDA 510(k) clearance K905311 for DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD., Substantially Equivalent on 1991-01-15. Applicant: Baxter Bentley Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Bentley Laboratories, Inc.
Product code: Code DWD
Device class: Class 2
Regulation: 21 CFR 870.4430
Advisory panel: Cardiovascular
Date received: 1990-11-28
Decision date: 1991-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWD

view all

K992657 — IBC VRV, MODEL 13502000-02-18
K920077 — NIKKISO NK PUMP1993-09-29
K915480 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.1992-01-07
K915481 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT1992-01-07
K915482 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT1992-01-07

More clearances from Baxter Bentley Laboratories, Inc.

view all

K905312 — DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS1991-01-15
K882892 — MEMBRANE OXYGENATOR1988-09-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.