510(k) K841959 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
CARDIO METRIC CUSTOM PERFUSION TUBING
| Applicant | Sterile Design, Inc., Oldsmar FL, US |
| Decision | Substantially Equivalent, Oct 19, 1984 |
| Received | May 14, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841959
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2006 | International Biophysics Corp IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX. Terminated |
DWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.