Super Torque
GC 6F.070 90CM JR4 ST
14manufacturers in China registered for this device type
1catalogue number
22510(k) clearances naming this product code
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 | Cordis Corp., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K021593 |
| Record published | 2016-08-01 |
| Record revised | 2024-10-14 (version 6) |
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 |
| Storage | Special storage condition: Exposure to temperatures above 54 degrees C (130 F) may damage the catheter; Special storage condition: Store in cool, dark, dry place; Special storage condition: Do not use if package is damanged; Special storage condition: To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SM7670 | 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 |
|---|---|
| K143412 | 2015-01-14 |
| K021593 | 2002-06-13 |
| K003920 | 2001-06-15 |
| K001136 | 2000-04-28 |
| K000715 | 2000-03-31 |
| K992673 | 1999-10-12 |
| K982632 | 1998-08-18 |
| K982770 | 1998-08-18 |
| K972978 | 1997-10-21 |
| K971572 | 1997-07-14 |
| K963962 | 1997-05-07 |
| K965211 | 1997-03-11 |
| K962830 | 1996-10-17 |
| K962362 | 1996-08-08 |
| K952185 | 1995-08-02 |
| K925131 | 1993-05-06 |
| K921311 | 1992-09-09 |
| K915374 | 1992-02-14 |
| K915777 | 1992-02-11 |
| K912777 | 1991-09-20 |
| K862975 | 1986-09-23 |
| K811971 | 1981-08-13 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cordis US Corp. | 510(k) number | 2025-02-07 | Class II | Employee error | Catheter manufactured at the incorrect length. | 12 units | |
| Cordis US Corp. | 510(k) number | 2019-02-07 | Class III | Equipment maintenance | Frayed pieces of the mounting card being inside the primary packaging. | 23481 | 2021-11-03 |
| Cordis US Corp. | 510(k) number | 2004-12-07 | Not classified | Other | Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an ‘RDC’ shape rather than the ‘RDC(1)’ shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming w | 153 units | 2008-11-19 |
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.