FlowGuide

The FDA filing identifies FlowGuide model FG60F as a single-lumen, rapid-exchange guide extension catheter. Its description specifies a 150 cm device with a stainless steel shaft and a…

Registry build 21.09.26

The FDA filing identifies FlowGuide model FG60F as a single-lumen, rapid-exchange guide extension catheter. Its description specifies a 150 cm device with a stainless steel shaft and a radiopaque distal end.

The filing says FlowGuide is used with guide catheters to access selected regions of the coronary or peripheral vasculature and facilitate guidewire and interventional device placement and exchange. FG60F has nine distal shaft perfusion holes.

Listed Item

The FlowGuide is Rapid Exchange or so-called Monorail design. The FlowGuide has a distal shaft connected to a proximal shaft / push rod with a proximal end stop connected at the proximal end. The distal shaft is stainless-steel reinforced. The reinforced distal shaft ends in an integrated soft distal tip to facilitate advancement of the device through a guiding catheter and into the main coronary vessels. In addition, the outer surface of the distal shaft and tip are equipped with a hydrophilic coating and the inner surface with a silicon coating for increased lubricity. The distal shaft has a radiopaque distal tip that in conjunction with fluoroscopy, aids in the placement of the guide extension. The distal shaft of the FlowGuide has an additional radiopaque marker at the proximal end that in conjunction with fluoroscopy, aid in preventing distal shaft exit the guiding catheter. Furthermore, the FlowGuide has side holes in its distal shaft to allow blood flow through the side holes to distal vasculature to aid in reducing the risk of ischemia. The guide extension has two markers on the push rod that indicate approximately, the exit of the distal tip from the guiding catheter (brachial → 90 cm, femoral → 100 cm). The IMDS family of guide extensions will be used in guiding catheters of 90 and 100 cm length, supplied with accessories. The effective length of the guide extensions will be 150 cm. For FlowGuide, a flexible transition zone is present on the push rod as an additional aid for smooth entry of intravascular devices.

Design Details

Positioning marks are located 95 cm and 105 cm from the distal tip. The filing states that the FlowGuide perfusion holes are intended to reduce pressure dampening.

14manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code

Who Else Makes It

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

Chinese manufacturers registered for FDA product code DQY
Manufacturer City Province Registered as Device types
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Covidien Medical Products (Shanghai) Manufacturing LLC Shanghai Shanghai Contract manufacturer 8
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Goals Sterilization Co., Ltd. Jiaxing Zhejiang Contract manufacturer 26
Wuxi Goals Medical Technology Co., Ltd. Yixing Jiangsu Contract manufacturer 24
Suzhou Zenith Vascular Scitech Limited Suzhou Jiangsu Manufacturer 6
Haolang Technology (Foshan) Limited Corporation Foshan Guangdong Contract manufacturer 6
OrbusNeich Medical (Shenzhen) Co., Ltd. Shenzhen Guangdong Complaint-file establishment 5
Curatia Medical Limited Suzhou Jiangsu Specification developer 5
Shanghai Wallaby Medical Technologies Co., Inc. Shanghai Shanghai Contract manufacturer 5
DK Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 3

Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous

Record

Regulatory record for FlowGuide
Listed by Imds Operations B.V., Netherlands
FDA product code DQY
Device type Catheter, Percutaneous
Device class Class 2
Regulation 21 CFR 870.1250
Establishment Contract manufacturer, Manufacturer
510(k) K242337
Record published 2026-06-01

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, manufacturing date

Catalogue Numbers

Catalogue numbers for FlowGuide
Catalogue number Size Status
FG60F In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Launcher™ Medtronic, Inc. 3,805
Sherpa NX Balanced™ Medtronic, Inc. 1,523
Arrow Teleflex Medical LLC 1,249
Z2 Medtronic, Inc. 955
Vista Brite TIP Cordis Corp. 789
Mach1™ Boston Scientific Corporation 777
Sherpa NX Active Medtronic, Inc. 571
Zuma® Medtronic, Inc. 569
Convey Pendracare International B.V. 532
Taiga Medtronic, Inc. 307
RunWay™ Boston Scientific Corporation 300
ConcierGE Guiding Excellence™ Merit Medical Systems, Inc. 295

Showing 12 of 500. All products under Catheter, Percutaneous

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K242337 2025-04-17
K241611 2024-09-03
K223728 2023-07-13
K210431 2021-07-15
K210110 2021-03-31
K200324 2020-08-06
K191229 2020-01-21
K121077 2012-12-21

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