Atlas FDA

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring

FDA 510(k) clearance K230318 · decided 2023-04-07

Clearance details

K-number
K230318
Device name
Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring
Applicant
Corcym S.r.l.
Decision
Substantially Equivalent
Date received
2023-02-06
Decision date
2023-04-07
Days to decision
60 days
Clearance type
Traditional
Product code
KRH
Device class
2
Regulation number
870.3800
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Saluggia, IT
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707)Corcym S.r.l.2026-06-18
TriMemo™ SEMIRIGID ANNULOPLASTY RING (K260498)Corcym S.r.l.2026-04-14
Seguin Annuloplasty Ring (K253232)ABBOTT MEDICAL2025-10-29
Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982)Edwards Lifesciences, LLC2025-09-23
Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688)Edwards Lifesciences, LLC2025-09-17
TransForm McCarthy Mitral Annuloplasty Ring (TF) (K250859)Genesee Biomedical, Inc.2025-07-25
TransForm McCarthy Mitral Annuloplasty Ring (TF) (K232599)Genesee Biomedical, Inc.2024-04-09
WellsForm Tricuspid Annuloplasty Band (WF) (K230679)Genesee Biomedical, Inc.2023-05-26
TruForm Sievers Annuloplasty Ring (K202253)Genesee Biomedical, Inc.2020-10-06
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring (K201449)Medtronic, Inc.2020-07-01
Physio Flex Annuloplasty Ring (K192762)Edwards Lifesciences, LLC2019-12-16
NeoForm Annuloplasty Ring (K190506)Genesee Biomedical, Inc.2019-04-18

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CARBOMEDICS PROSTHETIC HEART VALVE, CARBOMEDICS® SUPRA-ANNULAR PROSTHETIC HEART VALVE, OPTIFORM® PROSTHETIC MITRAL HEART (P900060/S070)Corcym S.r.l.2026-07-28
Perceval Sutureless Heart Valve (P150011/S035)Corcym S.r.l.2025-12-22
Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros (P900060/S069)Corcym S.r.l.2025-12-17
PERCEVAL SUTURELESS HEART VALVE (P150011/S033)Corcym S.r.l.2025-10-28
Perceval Sutureless Heart Valve (P150011/S034)Corcym S.r.l.2025-10-28
CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V (P900060/S068)Corcym S.r.l.2025-05-15
PERCEVAL SUTURELESS HEART VALVE (P150011/S032)Corcym S.r.l.2025-04-01
Perceval Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve (P150011/S028)Corcym S.r.l.2025-03-12