510(k) K963756 ยท DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
IBC CARDIAC SUCTION WARD
| Applicant | International Biophysics Corp., Austin TX, US |
| Decision | Substantially Equivalent, Nov 14, 1997 |
| Received | Sep 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963756
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2015 | International Biophysics Corp. 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 Terminated |
DTS | None listed |
| Nov 23, 2011 | International Biophysics Corp IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015
For use in open h Terminated |
DTS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.