Panels › Cardiovascular › Product code OFL · Class 2
Percutaneous Sheath Introducer Kit
Regulation 870.1340
0510(k)s in 12 months (0 all time)
2recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in OFL
| Company | 510(k)s | Recalls |
|---|---|---|
| ARROW INTERNATIONAL, LLC | 0 | 2 |
| Galt Medical Corporation | 0 | 2 |
| Stradis Medical, LLC dba Stradis Healthcare | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
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