510(k) K101113 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
GUARDIAN II NC HEMOSTASIS VALVE
| Applicant | Zerusa Limited, Galway, IE |
| Decision | Substantially Equivalent, May 21, 2010 |
| Received | Apr 21, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Sep 17, 2012 | Vascular Solutions, Inc. Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102.
Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated Terminated |
DTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.