510(k) K030661 ยท MEA Pump, Infusion, Pca
STRYKER PAINPUMP2
| Applicant | Stryker Instruments, Kalamazoo MI, US |
| Decision | Substantially Equivalent, May 30, 2003 |
| Received | Mar 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker Sheath 17 gage 12 inch for use with Stryker Pain Pump, REF 540-428, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments Kalamazoo MI Terminated |
MEA | None listed |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments, Kalamazoo, MI. Terminated |
MEA | None listed |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments, Kalamazoo, MI. Terminated |
MEA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.