FDA Registration
Active
🇮🇹 Italy
Corcym S.r.l.
Reg #: 3005687633
·
FEI: 3005687633
·
Expires 2026
Products
8
Proprietary Names
58
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- Corcym S.r.l.
- Registration Number
- 3005687633
- FEI Number
- 3005687633
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA CRESCENTINO, SN
- City
- SALUGGIA Vercelli
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K260498
- PMA Number
- P900060
Owner / Operator
- Firm Name
- Corcym S.r.l.
- Operator Number
- 9083203
- Address
- Via Crescentino sn
- City
- Saluggia
- State
- Vercelli
- Postal Code
- 13040
- Country
- IT
US Agent
- Business Name
- Corcym Inc.
- Contact Name
- Christopher Horton
- Address
- 9800 Pyramid Ct Ste 400
- City
- Englewood
- State
- CO
- ZIP
- 80112
- Country
- US
- [email protected]
- Phone
- 603 9302332
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Heart-Valve, Prosthesis | DTJ | Class 1 | Cardiovascular | No | 2006-12-19 |
| Ring, Annuloplasty | KRH | Class 2 | Cardiovascular | No | 2026-04-16 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2025-09-05 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2006-12-19 |
| Aortic Annuloplasty Ring | PST | Class 2 | Cardiovascular | No | 2023-11-30 |
| Heart-Valve, Mechanical | LWQ | Class 3 | Unknown | No | 2006-12-19 |
| Heart-Valve, Non-Allograft Tissue | LWR | Class 3 | Unknown | No | 2016-01-27 |
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 2006-12-19 |
Proprietary Names
Carbomedics Stainless Steel Bendable Valve Handle VH-100
TriMemo Tricuspid Semirigid Annuloplasty Ring
MEMO 3D Rechord Semirigid Annuloplasty Ring
MEMO 3D Semirigid Annuloplasty Ring
MEMO 4D Semirigid Annuloplasty Ring
Detachable Cross Clamp Head Large (85mm tissue engagement pads) MI-XCHL-851
DeTACH Delivery System kit MI-XCDS-001
Detachable Cross Clamp Head Medium (65mm tissue engagement pads) MI-XCHM-651
Aortic Cross Clamp Delivery Device MI-XCDD-001
Detachable Cross Clamp Head Small (55mm tissue engagement pads) MI-XCHS-551
Aortic Cross Clamp Quick Release MI-XCQR-001
Intercostal Retractor System Kit MI-IRS-222
Accessory Tray TR-101
Extended UNI Handle ICV1342
Accessory Tray ICV1230
UNI Handle ICV0664
MEMO 4D Sizer set ICV1357
Carbomedics Annuloplasty Ring Sizer Set ARMI-700
MEMO 4D Accessory Tray ICV1358
Memo 3D Sizer Set ICV1340
Memo 3D Accessory Tray ICV1343
Retractor Rack MI-IRS-R-001
Sterilization Tray MI-IRS-T-22
Suture Belt Organizer MI-ISBA-001
Collar Papillary Muscle Exposure Device MI-COTIE-001
Cuff Aortic Root Exposure Device MI-CUFF-001
Joseph Lamelas Atrial Lift System MI-ALS-001
Medium Blade Pair MI-IRS-MB-P01
TriMemo sizer set ICV1362
Large Blade Pair MI-IRS-LB-P01
Aortic Cross Clamp System Tray MI-XC-T-001
Small Double Swivel Blade MI-IRS-SDSB-22
Small Blade Pair MI-IRS-SB-P01
Extra Large Blade Pair MI-IRS-XLB-P01
Knot Pusher MI-KP-001
Medium Double Swivel Blade MI-IRS-MDSB-22
Carbomedics Annuloflex Annuloplasty Ring
HAART 200 Aortic Annuloplasty Device and accessories
HAART 300 Aortic Annuloplasty Device and accessories
Carbomedics Annuloflo Annuloplasty Ring
Memo 3D ReChord Semirigid Annuloplasty Ring
Memo 3D Semirigid Annuloplasty Ring
Memo 4D Semirigid Annuloplasty Ring
Carbomedics Orbis Prosthetic Heart Valve
Carbomedics Carbo-Seal Valsalva Ascending Aortic Prosthesis (AAP)
Aortic Rotators Set AR-150
Carbomedics Prosthetic Heart Valve (CPHV)
Carbomedics Carbo-Seal Ascending Aortic Prosthesis (AAP)
Carbomedics Optiform Prosthetic Heart Valve
Perceval Sutureless Heart Valve
Single Use MICS Accessory Kit
Single Use Accessory Kit
Dual Collapser Base
Perceval RelyON PAK accessories kit
Carbomedics Sizer Set VS2-1618
Perceval Sizer Set ICV1219
Carbomedics Sizer Set VS-200
Carbomedics Supra-Annular Sizer Set SAS-200
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)