IBC CARDIAC SUCTION WARD— 510(k) K963756

Name: FDA 510(k) clearance K963756
Creator: U.S. Food and Drug Administration
Published: 1997-11-14

Substantially Equivalent

International Biophysics Corp.

FDA 510(k) clearance K963756 for IBC CARDIAC SUCTION WARD, Substantially Equivalent on 1997-11-14. Applicant: International Biophysics Corp.. Device class: 2.

Clearance details

Applicant: International Biophysics Corp.
Product code: Code DTS
Device class: Class 2
Regulation: 21 CFR 870.4420
Advisory panel: Cardiovascular
Date received: 1996-09-17
Decision date: 1997-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K963756

K-number listed on FDA's recall record

Z-2422-2015 — IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.Class II·Terminated·International Biophysics Corp.·20150807

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963756.

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