CPS Direct™
MediGuide Enabled Slittable Outer Guide Catheter
14manufacturers in China registered for this device type
67catalogue numbers in this listing
13510(k) clearances naming this product code
1recall
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 | St. Jude Medical, United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K092075 |
| Record published | 2015-03-19 |
| Record revised | 2024-10-28 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dark, dry place.; Handling environment temperature -5 to 50 °C; Storage environment temperature 23 to 122 °F; Handling environment temperature 23 to 122 °F; Storage environment temperature -5 to 50 °C |
| Sizes | Catheter gauge 9 to 10.36 Fr; length 42 to 238.7 cm; length 18.5 in |
| Distribution end date | 2018-04-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DS2A004 | In distribution | |
| 410221 | Catheter Gauge 9.0000 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| DS2C018 | Catheter Gauge 10.06 Fr | In distribution |
| DS2C011 | Catheter Gauge 9 Fr | In distribution |
| 410224 | Catheter Gauge 9.0000 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| DS2M022 | Length 47 cm | In distribution |
| DS2C027 | Catheter Gauge 10.06 Fr | In distribution |
| DS2C023 | Catheter Gauge 10.06 Fr | In distribution |
| DS2C001 | Catheter Gauge 9 Fr | In distribution |
| 410219 | Catheter Gauge 9.0000 Fr | In distribution |
| DS2C019 | Catheter Gauge 10.06 Fr | In distribution |
| 410223 | Catheter Gauge 9.0000 Fr | In distribution |
| DS2C002 | Catheter Gauge 9 Fr | In distribution |
| 410218 | Length 54.0000 cm | In distribution |
| 410215 | Length 47.0000 cm | In distribution |
| 410210 | Catheter Gauge 9.0000 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| DS2M023 | Length 47 cm | In distribution |
| DS2C030 | Catheter Gauge 10.06 Fr | In distribution |
| DS2M042 | Length 47 cm | In distribution |
| DS2M041 | Catheter Gauge 10.36 Fr | In distribution |
| DS2C015 | Catheter Gauge 9 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| DS2C022 | Catheter Gauge 10.06 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| 410220 | Length 54.0000 cm | In distribution |
| DS2C006 | Catheter Gauge 9 Fr | In distribution |
| DS2M044 | Length 47 cm | In distribution |
| 410222 | Catheter Gauge 9.0000 Fr | In distribution |
| DS2C003 | Catheter Gauge 9 Fr | In distribution |
| DS2C004 | Catheter Gauge 9 Fr | In distribution |
| PL | In distribution | |
| DS2M021 | Length 18.5 in | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| 410214 | Length 47.0000 cm | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| DS2C014 | Catheter Gauge 9 Fr | In distribution |
| DS2C013 | Catheter Gauge 9 Fr | In distribution |
| DS2C024 | Catheter Gauge 10.06 Fr | In distribution |
| DS2C026 | Catheter Gauge 10.06 Fr | In distribution |
| 410225 | Catheter Gauge 9.0000 Fr | In distribution |
| 410213 | Length 47.0000 cm | In distribution |
| DS2C012 | Catheter Gauge 9 Fr | In distribution |
| DS2C029 | Length 42.0000 cm | In distribution |
| 410212 | Length 47.0000 cm | In distribution |
| 410211 | Length 47.0000 cm | In distribution |
| DS2C020 | Catheter Gauge 10.06 Fr | In distribution |
| 410217 | Length 54.0000 cm | In distribution |
| DS2C025 | Catheter Gauge 10.06 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| DS2C005 | Catheter Gauge 9 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| 410216 | Catheter Gauge 9.0000 Fr | In distribution |
| DS2M043 | Catheter Gauge 10.36 Fr | In distribution |
| DS2C028 | Catheter Gauge 10.06 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| PL | Catheter Gauge 9 Fr | In distribution |
| DS2C021 | Catheter Gauge 10.06 Fr | In distribution |
| SLII | 115-S | Withdrawn |
| SLII | Catheter Gauge 9 Fr | Withdrawn |
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 |
|---|---|
| K142235 | 2014-12-18 |
| K142239 | 2014-12-18 |
| K131592 | 2014-01-31 |
| K131063 | 2013-08-15 |
| K130257 | 2013-03-20 |
| K130252 | 2013-03-20 |
| K082932 | 2008-12-12 |
| K073700 | 2008-10-02 |
| K063638 | 2007-05-11 |
| K061843 | 2006-08-01 |
| K061710 | 2006-07-14 |
| K053217 | 2006-03-08 |
| K053277 | 2006-02-24 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-01-18 | Class I | Device Design | The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions. | 635 | 2013-05-21 |
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.