Guideliner
GuideLiner V3 catheter 5.5F
14manufacturers in China registered for this device type
34catalogue numbers in this listing
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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K212211 |
| Record published | 2024-07-12 |
| Record revised | 2024-01-23 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box, case of 50, peel pack, case of 5 |
| Sizes | Catheter gauge 5 to 8 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN922577 | In distribution | |
| 5573 | In distribution | |
| IPN922580 | In distribution | |
| IPN922578 | In distribution | |
| IPN920313 | Catheter Gauge 5.5 Fr | In distribution |
| IPN915841 | Catheter Gauge 6 Fr | In distribution |
| IPN930189 | In distribution | |
| IPN913568 | Catheter Gauge 6 Fr | In distribution |
| IPN913570 | Catheter Gauge 7 Fr | In distribution |
| IPN915843 | Catheter Gauge 8 Fr | In distribution |
| IPN931268 | Catheter Gauge 7 Fr | In distribution |
| IPN915842 | Catheter Gauge 7 Fr | In distribution |
| IPN913565 | Catheter Gauge 5 Fr | In distribution |
| 5572 | In distribution | |
| IPN920315 | Catheter Gauge 7 Fr | In distribution |
| IPN931266 | Catheter Gauge 5.5 Fr | In distribution |
| IPN913572 | Catheter Gauge 8 Fr | In distribution |
| IPN930191 | In distribution | |
| IPN931269 | Catheter Gauge 8 Fr | In distribution |
| IPN920316 | Catheter Gauge 8 Fr | In distribution |
| IPN915839 | Catheter Gauge 5 Fr | In distribution |
| IPN931265 | Catheter Gauge 5 Fr | In distribution |
| IPN930188 | In distribution | |
| IPN931267 | Catheter Gauge 6 Fr | In distribution |
| 5569 | In distribution | |
| IPN915840 | Catheter Gauge 5.5 Fr | In distribution |
| IPN913566 | Catheter Gauge 5.5 Fr | In distribution |
| IPN922787 | Catheter Gauge 6 Fr | In distribution |
| IPN929286 | Catheter Gauge 5.5 Fr | In distribution |
| 5570 | In distribution | |
| IPN930190 | In distribution | |
| IPN920314 | Catheter Gauge 6 Fr | In distribution |
| 5571 | In distribution | |
| IPN922579 | 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
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.