510(k) K133076 ยท OCY Endoscopic Guidewire, Gastroenterology-Urology
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
| Applicant | Neometrics, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 20, 2014 |
| Received | Sep 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2014 | NEO METRICS, INC. Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN Terminated |
OCY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.