510(k) K803277 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
TYGON TUBING
| Applicant | Electromedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 13, 1981 |
| Received | Dec 29, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K803277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2018 | Medtronic Perfusion Systems RESERVOIR "Y" ADAPTER,
(a) BT920
(b) BT926
Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir. Open, Classified |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.