510(k) K130430 ยท HRX Arthroscope
IVAS 10MM AND 15MM BALLOON CATHETER
| Applicant | Stryker Corporation, Kalamazoo MI, US |
| Decision | Substantially Equivalent, May 23, 2013 |
| Received | Feb 20, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130430
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969
for spinal orthopedic use. Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.