Panels › Cardiovascular › Product code OFC · Class 2
Catheter Introducer Kit
Regulation 870.1340
0510(k)s in 12 months (1 all time)
3recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in OFC
| Company | 510(k)s | Recalls |
|---|---|---|
| ARROW INTERNATIONAL, LLC | 0 | 3 |
| Prytime Medical Devices, Inc. | 0 | 1 |
| Spectranetics Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2010 | K093257 | TORQMAX SHEATH GRIP ACCESSORY Spectranetics Corp. | OFC |
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