ENCORE 26 ADVANTAGE KIT
FDA 510(k) clearance K120694 · decided 2012-04-03
Clearance details
- K-number
- K120694
- Device name
- ENCORE 26 ADVANTAGE KIT
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2012-03-07
- Decision date
- 2012-04-03
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- MAV
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.