MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
FDA 510(k) clearance K132623 · decided 2013-12-19
Clearance details
- K-number
- K132623
- Device name
- MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
- Applicant
- Medtronic
- Decision
- Substantially Equivalent
- Date received
- 2013-08-22
- Decision date
- 2013-12-19
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Rosa, 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 |
|---|---|---|
| HeartWare HVAD System (P100047/S227) | Medtronic | 2025-07-09 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S230) | Medtronic | 2025-06-26 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S229) | Medtronic | 2025-06-05 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228) | Medtronic | 2025-06-04 |
| HeartWare HVAD System (P100047/S226) | Medtronic | 2025-05-05 |
| HeartWare® HVAD System (P100047/S225) | Medtronic | 2025-04-24 |
| HeartWare HVAD System (P100047/S224) | Medtronic | 2025-04-02 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222) | Medtronic | 2025-03-13 |