AMPLATZER TORQVUE FX
FDA 510(k) clearance K121611 · decided 2012-08-23
Clearance details
- K-number
- K121611
- Device name
- AMPLATZER TORQVUE FX
- Applicant
- Aga Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-06-01
- Decision date
- 2012-08-23
- Days to decision
- 83 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model #'s recall (Z-0763-2013) | St Jude Medical Inc | 2013-02-11 |