Data / Medical devices / Italy / Corcym S.r.l.
Corcym S.r.l.: FDA-registered device maker in SALUGGIA Vercelli, Italy, 8 510(k) clearances and 2 PMA approvals
Corcym S.r.l. is registered with the FDA (registration 3005687633) in SALUGGIA Vercelli, Italy. It lists 8 device types. The FDA files 8 510(k) clearances and 2 PMA approvals under its listings, the newest dated June 18, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005687633
- Address
- Via Crescentino, SN, SALUGGIA Vercelli, Italy, 13040
- Owner or operator
- Corcym S.r.l. (9083203)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- May 5, 2006
- Registered through
- 2026
- Brand names listed
- Accessory Tray ICV1230, Accessory Tray TR-101, Aortic Cross Clamp Delivery Device MI-XCDD-001, Aortic Cross Clamp Quick Release MI-XCQR-001, Aortic Cross Clamp System Tray MI-XC-T-001, Aortic Rotators Set AR-150, Carbomedics Annuloflex Annuloplasty Ring, Carbomedics Annuloflo Annuloplasty Ring and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aortic Annuloplasty Ring | PST | 2 | Contract manufacturer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Specification developer | accessdata.fda.gov |
| Heart-Valve, Mechanical | LWQ | 3 | Manufacturer | accessdata.fda.gov |
| Heart-Valve, Non-Allograft Tissue | LWR | 3 | Manufacturer | accessdata.fda.gov |
| Holder, Heart-Valve, Prosthesis | DTJ | 1 | Manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ring, Annuloplasty | KRH | 2 | Manufacturer | accessdata.fda.gov |
| Sizer, Heart-Valve, Prosthesis | DTI | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2026 | K261707 | MEMO 4D Curve Semirigid mitral annuloplasty ring | KRH | Substantially Equivalent | Corcym S.r.l. | accessdata.fda.gov |
| April 14, 2026 | K260498 | TriMemo SEMIRIGID ANNULOPLASTY RING | KRH | Substantially Equivalent | Corcym S.r.l. | accessdata.fda.gov |
| April 7, 2023 | K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring | KRH | Substantially Equivalent | Corcym S.r.l. | accessdata.fda.gov |
| March 4, 2021 | K210006 | MI DeTACH | DXC | Substantially Equivalent | Biorep Technologies, Inc. | accessdata.fda.gov |
| March 16, 2018 | K180411 | MEMO 4D | KRH | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| August 29, 2014 | K142221 | MEMO 3D ReChord | KRH | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| December 17, 2002 | K023185 | ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 | KRH | Substantially Equivalent | Sulzer Carbomedics, Inc. | accessdata.fda.gov |
| April 23, 2002 | K021051 | ANNULOFLO SYSTEM, MITRAL MODEL AR700 | KRH | Substantially Equivalent | Sulzer Carbomedics, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 8, 2016 | P150011 | PERCEVAL SUTURELESS HEART VALVE | LWR | 34 | December 22, 2025 | accessdata.fda.gov |
| September 29, 1993 | P900060 | CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) | LWQ | 63 | July 28, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 29, 2020 | 86161 | Class II | Terminated | Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S | accessdata.fda.gov |
Compare with other makers
- All makers of Ring, Annuloplasty
- All makers of Heart-Valve, Non-Allograft Tissue
- All makers of Aortic Annuloplasty Ring
- All makers of Clamp, Vascular
- All makers of Sizer, Heart-Valve, Prosthesis
- All makers of Instruments, Surgical, Cardiovascular
Updated June 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.