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 |