510(k) K812973 ยท DYB Introducer, Catheter
PERCUTANEOUS INTRODUCER COURNAND STYLE
| Applicant | Dip, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Nov 16, 1981 |
| Received | Oct 23, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812973
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2015 | Stryker Instruments Div. of Stryker Corporation Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle)
20 units per case
The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.