TorqVue Low Profile Delivery Catheter
FDA 510(k) clearance K162228 · decided 2016-09-09
Clearance details
- K-number
- K162228
- Device name
- TorqVue Low Profile Delivery Catheter
- Applicant
- Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor
- Decision
- Substantially Equivalent
- Date received
- 2016-08-08
- Decision date
- 2016-09-09
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 recall (Z-1644-2025) | Abbott | 2025-04-21 |