MEMO 3D SEMIRIGID ANNULOPLASTY RING— 510(k) K071327

Name: FDA 510(k) clearance K071327
Creator: U.S. Food and Drug Administration
Published: 2007-08-10

Substantially Equivalent

Sorin Biomedica Cardio S.R.L.

FDA 510(k) clearance K071327 for MEMO 3D SEMIRIGID ANNULOPLASTY RING, Substantially Equivalent on 2007-08-10. Applicant: Sorin Biomedica Cardio S.R.L.. Device class: 2.

Clearance details

Applicant: Sorin Biomedica Cardio S.R.L.
Product code: Code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 2007-05-11
Decision date: 2007-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRH

view all

K261707 — MEMO 4D Curve Semirigid mitral annuloplasty ring2026-06-18
K260498 — TriMemo SEMIRIGID ANNULOPLASTY RING2026-04-14
K253232 — Seguin Annuloplasty Ring2025-10-29
K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)2025-09-23
K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)2025-09-17

Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.