510(k) K820297 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
WM. HARVEY OVERPRESSURE SAFETY VALVE
| Applicant | C.R. Bard, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 12, 1982 |
| Received | Feb 4, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2017 | Terumo Cardiovascular Systems Corporation TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J Terminated |
DTL | None listed |
| Jun 27, 2017 | Terumo Cardiovascular Systems Corporation Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J
Catalog numbers:
US distribution:
LH130
74369
71156 Terminated |
DTL | None listed |
| Jun 23, 2015 | Terumo Cardiovascular Systems Corp Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves.
For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. Terminated |
DTL | None listed |
| Dec 27, 2013 | Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line Terminated |
MNJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.