AMPLATZER TorqVue 45x45 Delivery Sheath
FDA 510(k) clearance K163000 · decided 2016-12-23
Clearance details
- K-number
- K163000
- Device name
- AMPLATZER TorqVue 45x45 Delivery Sheath
- Applicant
- Aga Medical COrporation (Wholly Owned by St. Jude Medical CO
- Decision
- Substantially Equivalent
- Date received
- 2016-10-28
- Decision date
- 2016-12-23
- Days to decision
- 56 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
No recalls on record reference this clearance.