FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Edwards MC3 Tricuspid annuloplasty ring (4900)
K Number: K251982
·
Decision Sep 23, 2025
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
74
Applicant Total
136
Review Days
88
Basic Information
- Device Name
- Edwards MC3 Tricuspid annuloplasty ring (4900)
- K Number
- K251982
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.3800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifesciences, LLC
- Date Received
- June 27, 2025
- Decision Date
- September 23, 2025
- 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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|---|---|---|---|
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| K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Aug 2, 2024 | Substantially Equivalent |
| K233824 | Swan-Ganz catheter | Jun 6, 2024 | Substantially Equivalent |
| K233819 | Fogarty Venous Thrombectomy Catheters | May 22, 2024 | Substantially Equivalent |
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