FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Seguin Annuloplasty Ring
K Number: K253232
·
Decision Oct 29, 2025
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
74
Applicant Total
57
Review Days
30
Basic Information
- Device Name
- Seguin Annuloplasty Ring
- K Number
- K253232
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT MEDICAL
- Date Received
- September 29, 2025
- Decision Date
- October 29, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRH), ordered by most recent decision date.
MEMO 4D Curve Semirigid mitral annuloplasty ring
FDA 510(k)
FDA Class 2
·Cardiovascular
TriMemo SEMIRIGID ANNULOPLASTY RING
FDA 510(k)
FDA Class 2
·Cardiovascular
Edwards MC3 Tricuspid annuloplasty ring (4900)
FDA 510(k)
FDA Class 2
·Cardiovascular
Carpentier-Edwards Physio Annuloplasty Ring (4450)
FDA 510(k)
FDA Class 2
·Cardiovascular
TransForm McCarthy Mitral Annuloplasty Ring (TF)
FDA 510(k)
FDA Class 2
·Cardiovascular
TransForm McCarthy Mitral Annuloplasty Ring (TF)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by ABBOTT MEDICAL
| K Number | Device Name | ||
|---|---|---|---|
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | Apr 24, 2026 | Substantially Equivalent |
| K260212 | EnSite X EP System | Apr 20, 2026 | Substantially Equivalent |
| K253907 | Disposable Radiofrequency Cannula | Apr 16, 2026 | Substantially Equivalent |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | Mar 13, 2026 | Substantially Equivalent |
| K252512 | Armada 14 NC PTA Catheter | Feb 13, 2026 | Substantially Equivalent |
| K253516 | Assert-IQ (DM5100) | Dec 18, 2025 | Substantially Equivalent |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | Dec 17, 2025 | Substantially Equivalent |
| K250031 | Amplatzer Guidewire | Oct 3, 2025 | Substantially Equivalent |
| K252013 | EnSite X EP System | Sep 25, 2025 | Substantially Equivalent |
| K251463 | EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | Sep 4, 2025 | Substantially Equivalent |