Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
FDA 510(k) clearance K190132 · decided 2019-07-30
Clearance details
- K-number
- K190132
- Device name
- Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
- Applicant
- Medtronic
- Decision
- Substantially Equivalent
- Date received
- 2019-01-28
- Decision date
- 2019-07-30
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mounds View, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartWare HVAD System (P100047/S240) | Medtronic | 2026-08-05 |
| HeartWare® Ventricular Assist System (P100047/S239) | Medtronic | 2026-07-28 |
| Heart Ware Ventricular Assist System (HVAD) (P100047/S238) | Medtronic | 2026-05-14 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S223) | Medtronic | 2026-04-10 |
| HeartWare HVAD System (P100047/S235) | Medtronic | 2026-04-07 |
| HeartWare® HVAD System (P100047/S234) | Medtronic | 2026-02-18 |
| HeartWare® HVAD System (P100047/S236) | Medtronic | 2026-02-03 |
| HeartWare HVAD System (P100047/S227) | Medtronic | 2025-07-09 |