510(k) K082349 ยท HDC Tenaculum, Uterine
JARIT HULKA UTERINE TENACULUM FORCEPS
| Applicant | J. Jamner Surgical Instruments, Inc., York PA, US |
| Decision | Substantially Equivalent, Nov 21, 2008 |
| Received | Aug 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082349
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2014 | Medtronic Vascular, Inc. FIBERNET Embolic Protection System:
Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter:
0.014 in (0.36mm)
Rx only, Sterile;
Manufactured in:
Invatec S.P.A., Italy;
Manufacturer:
Medtr Terminated |
NTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.