FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
K Number: K073324
·
Decision Mar 13, 2008
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
74
Applicant Total
209
Review Days
107
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Basic Information
- Device Name
- MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
- K Number
- K073324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- November 27, 2007
- Decision Date
- March 13, 2008
- Product Code
- KRH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KRH | Ring, Annuloplasty | FDA class 2 | Cardiovascular |
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