FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEGUIN ANNULOPLASTY RING
K Number: K092310
·
Decision Aug 27, 2009
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
68
Applicant Total
93
Review Days
29
Basic Information
- Device Name
- SEGUIN ANNULOPLASTY RING
- K Number
- K092310
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ST. JUDE MEDICAL
- Date Received
- July 29, 2009
- Decision Date
- August 27, 2009
- 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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