FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
K Number: K052899
·
Decision Nov 17, 2005
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
74
Applicant Total
14
Review Days
34
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Basic Information
- Device Name
- ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
- K Number
- K052899
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genesee Biomedical, Inc.
- Date Received
- October 14, 2005
- Decision Date
- November 17, 2005
- 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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| K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | Feb 25, 2009 | Substantially Equivalent |