Zoom 6f Insert Catheter, VTK

The Zoom 6F Insert Catheter delivers radiopaque contrast medium to selected peripheral blood vessels during diagnostic procedures. The VTK version has a preshaped distal curve for…

Registry build 21.09.26

The Zoom 6F Insert Catheter delivers radiopaque contrast medium to selected peripheral blood vessels during diagnostic procedures. The VTK version has a preshaped distal curve for selectively engaging arteries and a working length of 140 centimetres.

Its single lumen is surrounded by a braided, variable-stiffness shaft. The tapered distal tip and distal shaft are radiopaque. A proximal Luer hub connects to compatible equipment such as a syringe, while the catheter advances over a guidewire using standard angiographic techniques.

Listed Item

Zoom 6F Insert Catheter, VTK, 140cm

Compatible Equipment

The catheter accepts guidewires no wider than 0.038 inches and at least 180 centimetres long. It requires an introducer sheath of at least 6 French and a guide catheter with an internal diameter of at least 0.088 inches.

11manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DQO
Manufacturer City Province Registered as Device types
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Bioxin Medical Co., Ltd. Weihai Shandong Contract manufacturer 8
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Goals Sterilization Co., Ltd. Jiaxing Zhejiang Contract manufacturer 26
Wuxi Goals Medical Technology Co., Ltd. Yixing Jiangsu Contract manufacturer 24
Sunny Medical Device (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Curatia Medical Limited Suzhou Jiangsu Specification developer 5
Shenzhen Vivolight Medical Device&Technology Co., Ltd. Shenzhen Guangdong Manufacturer 4
Shenzhen Antmed Co., Ltd. Dongguan Guangdong Manufacturer 4

Record

Regulatory record for Zoom 6F Insert Catheter, VTK
Listed by Imperative Care Inc., United States
FDA product code DQO
Device type Catheter, Intravascular, Diagnostic
Device class Class 2
Regulation 21 CFR 870.1200
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K233975
Record published 2024-06-18
Record revised 2025-02-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Special storage condition: Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.; Special storage condition: Store in a cool, dry place at room temperature.
Sizes Catheter length 140 cm; outer diameter 0.082 in; lumen/inner diameter 0.041 in

Catalogue Numbers

Catalogue numbers for Zoom 6F Insert Catheter, VTK
Catalogue number Size Status
IC6FVTK140 Catheter Length 140 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Performa® Merit Medical Systems, Inc. 1,101
Impress® Merit Medical Systems, Inc. 839
Super Torque Cordis Corp. 611
Soft-Vu AngioDynamics, Inc. 591
Torcon NB Cook Incorporated 463
Mariner AngioDynamics, Inc. 323
INT,SlideCath Shanghai Kindly Medical Instruments Co., Ltd. 264
Infiniti Cordis Corp. 251
Infiniti Cordis US Corp. 241
AngiOptic AngioDynamics, Inc. 227
Tempo Cordis Corp. 217
SiteSeer™ Medtronic, Inc. 204

Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K233975 2024-04-02

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