TIE Intracorporeal Knot Placement Assist and Collar Papillary Muscle Exposure

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…

Registry build 21.09.26

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.

6manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code DWS
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22
Huaian Wolfram Surgical Instruments Huaian Jiangsu Manufacturer 14
Global Medical Production Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Record

Regulatory record for TIE Intracorporeal Knot Placement Assist and Collar Papillary Muscle Exposure
Listed by Corcym Inc., United States
FDA product code DWS
Device type Instruments, Surgical, Cardiovascular
Device class Class 1
Regulation 21 CFR 870.4500
Establishment Manufacturer
Premarket notification Exempt
Record published 2026-02-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Packaging Shelf box of 6

Catalogue Numbers

Catalogue numbers for TIE Intracorporeal Knot Placement Assist and Collar Papillary Muscle Exposure
Catalogue number Size Status
MI-COTIE-001 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Delacroix-Chevalier Landanger 1,819
Landanger Landanger 1,213
Ambler Surgical Ambler Surgical, LLC 1,013
Pilling Teleflex Medical LLC 971
Wexler Surgical, Inc. Wexler Surgical, Inc. 876
V. Mueller Steris Corporation 716
Novo Surgical Novo Surgical, Inc. 387
Integra® Jarit® Integra LifeSciences Production Corporation 364
Instruments, Surgical, Cardiovascular Fehling Instruments GmbH 352
Novo Surgical Inc. Novo Surgical, Inc. 290
Avalign Avalign Technologies, Inc. 283
Millennium Avalign Technologies, Inc. 272

Showing 12 of 472. All products under Instruments, Surgical, Cardiovascular

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer