TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle Exposure MI-COTIE-001

GUDID 18022057015867

The TIE device is a tourniquet-style surgical instrument used to control the target location of knot seating during precise suture knot tying and delivery applications. The COLLAR device is a flexible surgical retractor designed to retract valve leaflet tissue when inserted within the valve annulus. The device consists of a main body component which extends laterally to become the retraction wings. The distal tips of the retraction wings are bifurcated for additional tissue traction. The posterior aspect of the device has a stiffening rib along the superior border and a stabilization flange along the inferior border. The COLLAR device is available in 2 sizes (small and large) which are packaged together in a disposable set with the TIE device.

CORCYM SRL

Suturing unit, single-use

• Primary Device ID: 18022057015867
• NIH Device Record Key: 044e4f78-9af6-4ae4-b8bf-df4b20a427ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle Exposure
• Version Model Number: MI-COTIE-001
• Catalog Number: MI-COTIE-001
• Company DUNS: 441454802
• Company Name: CORCYM SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08022057015860 [Primary]
GS1	18022057015867 [Package]; Contains: 08022057015860; Package: SHELF BOX [6 Units]; In Commercial Distribution

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-11
• Device Publish Date: 2026-02-03

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