LEFT VENTRICULAR VENT VALVE MODEL NO. GLV— 510(k) K862540

Name: FDA 510(k) clearance K862540
Creator: U.S. Food and Drug Administration
Published: 1986-08-29

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K862540 for LEFT VENTRICULAR VENT VALVE MODEL NO. GLV, Substantially Equivalent on 1986-08-29. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DWD
Device class: Class 2
Regulation: 21 CFR 870.4430
Advisory panel: Cardiovascular
Date received: 1986-07-02
Decision date: 1986-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, 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 Gish Biomedical, Inc.

view all

K090449 — MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT2009-09-18
K090450 — MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT2009-09-18
K091062 — MEDOS HILITE INFANT RESERVOIR, MODEL MVC 07302009-08-04
K083131 — MEDOS HILITE RESERVOIR, MODEL: 40302009-07-30
K082403 — MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT2009-05-15

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