Cardio Flow Peripheral Guide Wire
The Cardio Flow Peripheral Guide Wire provides a temporary track for placing or exchanging diagnostic and treatment devices in peripheral blood vessels. Model GW1001 is 325 cm long with a…
The Cardio Flow Peripheral Guide Wire provides a temporary track for placing or exchanging diagnostic and treatment devices in peripheral blood vessels. Model GW1001 is 325 cm long with a maximum outer diameter of 0.014 inches.
The guidewire has a 304V stainless steel mandrel and a fixed spring coil at its distal end. The coil is visible under fluoroscopy, and the distal section has a hydrophobic silicone coating to support tracking.
Listed Item
Cardio Flow Peripheral Guide Wire Guidewire, 325 CM
Construction and Use
The distal coil has medium stiffness and forms the guidewire’s leading segment during device placement. The wire is intended specifically for peripheral vascular procedures. It is supplied sterile after ethylene oxide sterilization and is a disposable, single-use device.
Who Else Makes It
Concentrated in Beijing (4), Jiangsu (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Cardio Flow, Inc., United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K213834 |
| Record published | 2024-06-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 30 to 50 % RH; Handling environment temperature 15 to 35 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 30 to 50 % RH; Storage environment temperature 15 to 35 °C |
| Packaging | Box, case of 5 |
| Sizes | Guidewire length 325 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GW1001 | Guidewire Length 325 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| Cook | Cook Incorporated | 410 |
| Guidewire | Argon Medical Devices, Inc. | 173 |
| Medline Industries, Inc. | Medline Industries, Inc. | 151 |
| Guidewire | Galt Medical Corp. | 144 |
| Amplatz | Cook Incorporated | 128 |
| InQwire® | Merit Medical Systems, Inc. | 120 |
| Angiographic Guide Wire | Medtronic, Inc. | 94 |
| Glidewire | Terumo Corp. | 83 |
| Starter™ Guidewire | Lake Region Medical Limited | 82 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
Showing 12 of 525. All products under Wire, Guide, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213834 | 2022-03-18 |
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.