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…
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.
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.
| 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
| 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
| 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 number | Size | Status |
|---|---|---|
| FG60F | In distribution |
Same 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
| 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.