Surefire Guiding Catheter
The Surefire Guiding Catheter provides a pathway for therapeutic devices into the peripheral vascular system. Its single-lumen, braided 5 F shaft has a soft rounded distal tip and preshaped…
The Surefire Guiding Catheter provides a pathway for therapeutic devices into the peripheral vascular system. Its single-lumen, braided 5 F shaft has a soft rounded distal tip and preshaped curves to support access and positioning.
The Pebax polymer contains a radiopaque additive for fluoroscopic visibility. A proximal luer lock hub and strain relief support connection to compatible infusion syringes or rotating hemostatic valves.
Listed Item
65cm, 5F Guiding Catheter with Cobra1 Shape
Compatibility and Supply
The catheter accepts a 0.038-inch guidewire and works with 5 F sheath introducers. The family includes 65 and 80 cm lengths with Axis, Simmons I and Cobra tip shapes. It is supplied ethylene oxide sterilized for single patient use.
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 | Surefire Medical, Inc., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K140034 |
| Record published | 2016-09-08 |
| Record revised | 2021-12-22 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Catheter gauge 5 Fr; length 65 cm; lumen/inner diameter 0.056 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SGC-5065-Axis | Catheter Gauge 5 Fr | In distribution |
| SGC-5065-Cobra1 | Length 65 cm | In distribution |
| SGC-5065-Sim1 | Catheter Gauge 5 Fr | 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 |
|---|---|
| K162359 | 2016-09-21 |
| K140034 | 2014-02-26 |
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.