The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Archer Super Stiff Guidewires.
| Device ID | K101339 |
| 510k Number | K101339 |
| Device Name: | ARCHER SUPER STIFF GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | MEDTRONIC INC. 3576 Unocal Place Santa Rosa, CA 95403 |
| Contact | Colleen Mullins |
| Correspondent | Colleen Mullins MEDTRONIC INC. 3576 Unocal Place Santa Rosa, CA 95403 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-12 |
| Decision Date | 2010-08-31 |
| Summary: | summary |