FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
K Number: K103520
·
Decision Jun 24, 2011
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
74
Applicant Total
136
Review Days
206
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Basic Information
- Device Name
- CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
- K Number
- K103520
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifesciences, LLC
- Date Received
- November 30, 2010
- Decision Date
- June 24, 2011
- 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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