510(k) K122301 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
| Applicant | Vascular Solutions Zerusa , Ltd., Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 7, 2012 |
| Received | Aug 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122301
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2016 | Vascular Solutions, Inc. Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50.
Product Usage: The Guardian hemostasis valves Terminated |
DTL | None listed |
| Mar 20, 2013 | Vascular Solutions, Inc. Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass.
Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, F Terminated |
DTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.