The following data is part of a premarket notification filed by Medcomp with the FDA for The Medcomp .010 Vascular Guidewires.
| Device ID | K081775 |
| 510k Number | K081775 |
| Device Name: | THE MEDCOMP .010 VASCULAR GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Lisa Weikert |
| Correspondent | Lisa Weikert MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-23 |
| Decision Date | 2009-03-25 |
| Summary: | summary |