510(k) K260498
K260498 is an FDA 510(k) premarket notification submitted by Corcym S.r.l. for the device "TriMemo SEMIRIGID ANNULOPLASTY RING". The FDA issued a decision of Substantially Equivalent on April 14, 2026. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Corcym S.r.l. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2026
- Date Received
- February 13, 2026
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ring, Annuloplasty
- Device Class
- Class II
- Regulation Number
- 870.3800
- Review Panel
- CV
- Submission Type