MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
FDA 510(k) clearance K073324 · decided 2008-03-13
Clearance details
- K-number
- K073324
- Device name
- MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-11-27
- Decision date
- 2008-03-13
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- KRH
- Device class
- 2
- Regulation number
- 870.3800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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