ROBICSEK INTRACARDIAC SUCTION WAND— 510(k) K891906

Name: FDA 510(k) clearance K891906
Creator: U.S. Food and Drug Administration
Published: 1989-06-13

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K891906 for ROBICSEK INTRACARDIAC SUCTION WAND, Substantially Equivalent on 1989-06-13. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTS
Device class: Class 2
Regulation: 21 CFR 870.4420
Advisory panel: Cardiovascular
Date received: 1989-03-27
Decision date: 1989-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTS

view all

K053021 — ESTECH CLEARVIEW MV ATRIAL DEPRESSOR2006-01-26
K982891 — CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS1998-09-30
K963756 — IBC CARDIAC SUCTION WARD1997-11-14
K905008 — FLEXIBLE INTRACARDIAC SUCTION DEVICE1991-01-23
K900339 — HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES1990-03-28

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.