Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005687633

FEI Number

3005687633

Entity Name

Corcym S.r.l.

City/State/Country

SALUGGIA Vercelli, IT

Establishment Address

VIA CRESCENTINO, SN, SALUGGIA Vercelli 13040, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Corcym S.r.l. (Owner Number: 9083203)

Owner / Operator Contact Address

Via Crescentino sn, Saluggia, IT-VC 13040, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTJ	Holder, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3935	2006-12-19
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2026-04-16
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2014-09-09
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2018-04-09
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2025-09-05
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2006-12-19
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2006-05-05
PST	Aortic Annuloplasty Ring	Cardiovascular	Class 2	870.3800	2023-11-30
PST	Aortic Annuloplasty Ring	Cardiovascular	Class 2	870.3800	2023-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

Christopher Horton Business: Corcym Inc. Email: christopher.horton@corcym.com Phone: (603) 9302332

Related Public Records

Same Entity

Corcym S.r.l.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3019892983	Corcym Inc.	Englewood, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K813276	Shiley, Inc.	IONESCU-SHILEY VALVE HOLDER & HANDLE	1981-12-10
K253232	ABBOTT MEDICAL	Seguin Annuloplasty Ring	2025-10-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

Registration Number	Establishment Name	Location
2135147	Abbott Medical	Plymouth, MN, US
2133928	Metal Craft Machine & Engineering, Inc.	Elk River, MN, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
2025587	Medtronic Heart Valves Division	Santa Ana, CA, US
3008592544	Medtronic, Inc. (Minneapolis, MN 55447)	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005687633. Last updated year: 2026. Please use registration number 3005687633 when referencing this establishment in official correspondence.