VS3-IR
FDA 510(k) clearance K183453 · decided 2019-03-04
Clearance details
- K-number
- K183453
- Device name
- VS3-IR
- Applicant
- Medtronic
- Decision
- Substantially Equivalent
- Date received
- 2018-12-13
- Decision date
- 2019-03-04
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- OWN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Petach Tikva, Hamerkaz, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| HeartWare HVAD System (P100047/S227) | Medtronic | 2025-07-09 |
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| 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 |