MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
FDA 510(k) clearance K961917 · decided 1996-11-20
Clearance details
- K-number
- K961917
- Device name
- MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
- Applicant
- Medtronics Interventional Vascular
- Decision
- Substantially Equivalent
- Date received
- 1996-05-17
- Decision date
- 1996-11-20
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER (P870036/S044) | Medtronics Interventional Vascular | 1998-11-17 |
| MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM (P960010/S001) | Medtronics Interventional Vascular | 1998-05-21 |
| MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER (P870036/S043) | Medtronics Interventional Vascular | 1997-08-12 |
| MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL (P870036/S042) | Medtronics Interventional Vascular | 1997-07-28 |
| MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM (P960010) | Medtronics Interventional Vascular | 1997-06-27 |
| MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS (P870036/S041) | Medtronics Interventional Vascular | 1997-03-07 |
| MEDTRONIC(R) FALCON(R) CORONARY BALLOON DILATATION CATHETERS (P870036/S040) | Medtronics Interventional Vascular | 1996-10-25 |
| MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS (P870036/S038) | Medtronics Interventional Vascular | 1996-09-25 |