The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Medtronic Mustang Steerable Guide Wire (m-45fr, M45fx).
| Device ID | K961917 |
| 510k Number | K961917 |
| Device Name: | MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) |
| Classification | Wire, Guide, Catheter |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 9410 CARROLL PARK DR. San Diego, CA 92121 -2256 |
| Contact | Mary De Armond |
| Correspondent | Mary De Armond MEDTRONICS INTERVENTIONAL VASCULAR 9410 CARROLL PARK DR. San Diego, CA 92121 -2256 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-17 |
| Decision Date | 1996-11-20 |
| Summary: | summary |