FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
K Number: K072655
·
Decision Oct 23, 2007
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
74
Applicant Total
14
Review Days
33
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Basic Information
- Device Name
- ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
- K Number
- K072655
- 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
- September 20, 2007
- Decision Date
- October 23, 2007
- 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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| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Apr 9, 2024 | Substantially Equivalent |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | May 26, 2023 | Substantially Equivalent |
| K202253 | TruForm Sievers Annuloplasty Ring | Oct 6, 2020 | Substantially Equivalent |
| K190506 | NeoForm Annuloplasty Ring | Apr 18, 2019 | Substantially Equivalent |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | Oct 12, 2016 | Substantially Equivalent |
| K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | Jul 15, 2010 | Substantially Equivalent |
| K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | May 7, 2009 | Substantially Equivalent |
| K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | Feb 25, 2009 | Substantially Equivalent |