The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Guidewire, Pursuer Series.
| Device ID | K130104 |
| 510k Number | K130104 |
| Device Name: | GUIDEWIRE, PURSUER SERIES |
| Classification | Wire, Guide, Catheter |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-15 |
| Decision Date | 2013-06-13 |