Cordis
Intro G 9F STR 95CM.035 Inches
14manufacturers in China registered for this device type
122catalogue numbers in this listing
1510(k) clearance
5recalls on this 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 US Corp., 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, Exporter |
| 510(k) | K963962 |
| Record published | 2017-09-18 |
| Record revised | 2025-09-05 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 588843T | In distribution | ||
| 5888202 | In distribution | ||
| 55811200 | In distribution | ||
| 588846P | In distribution | ||
| 588896 | In distribution | ||
| 588836 | In distribution | ||
| 67003600 | In distribution | ||
| 55818200 | In distribution | ||
| 5989206 | In distribution | ||
| 588837 | In distribution | ||
| 588883 | In distribution | ||
| 588892 | In distribution | ||
| 588841P | In distribution | ||
| 588834 | In distribution | ||
| 588858P | In distribution | ||
| 588832 | In distribution | ||
| 67027890 | In distribution | ||
| 588848P | In distribution | ||
| 5888108 | In distribution | ||
| 55840000 | In distribution | ||
| 598942 | In distribution | ||
| 55817400 | In distribution | ||
| 55616800 | In distribution | ||
| 598944P | In distribution | ||
| 588855 | In distribution | ||
| 588800 | In distribution | ||
| 5888101 | In distribution | ||
| 588820 | In distribution | ||
| 588812 | In distribution | ||
| 588830T | In distribution | ||
| 588894 | In distribution | ||
| 588851 | In distribution | ||
| 588880 | In distribution | ||
| 588831T | In distribution | ||
| 588801 | In distribution | ||
| 5888103 | In distribution | ||
| 588842 | In distribution | ||
| 588857P | In distribution | ||
| 55832000 | In distribution | ||
| 588848 | In distribution | ||
| 55606000 | In distribution | ||
| 55617400 | In distribution | ||
| 598943P | In distribution | ||
| 55816200 | In distribution | ||
| 55616200 | In distribution | ||
| 588854 | In distribution | ||
| 77800490 | In distribution | ||
| 55600800 | In distribution | ||
| 55811000 | In distribution | ||
| 67018090 | In distribution | ||
| 55605400 | In distribution | ||
| 55813000 | In distribution | ||
| 588890 | In distribution | ||
| 55827000 | In distribution | ||
| MODG18771 | 2 | In distribution | |
| 55605600 | In distribution | ||
| 588850 | In distribution | ||
| 5888100 | In distribution | ||
| 588852 | In distribution | ||
| 5888104 | In distribution | ||
| 4039953S | In distribution | ||
| 588891 | In distribution | ||
| 67200300 | In distribution | ||
| 55819000 | In distribution | ||
| 588831 | In distribution | ||
| 5888206 | In distribution | ||
| 588844P | In distribution | ||
| 67003500 | In distribution | ||
| 588843 | In distribution | ||
| 55827800 | In distribution | ||
| 77827890 | In distribution | ||
| SM7672 | In distribution | ||
| 588817 | In distribution | ||
| 588830 | In distribution | ||
| 67002800 | In distribution | ||
| 588845 | In distribution | ||
| 55617200 | In distribution | ||
| 588843P | In distribution | ||
| 588840P | In distribution | ||
| 55604000 | In distribution | ||
| 55611200 | In distribution | ||
| 77827990 | In distribution | ||
| 588845P | In distribution | ||
| 55805400 | In distribution | ||
| 588847 | In distribution | ||
| 588828 | In distribution | ||
| 55802600 | In distribution | ||
| 55803400 | In distribution | ||
| 598942P | In distribution | ||
| 588846 | In distribution | ||
| 77827055 | In distribution | ||
| 77804090 | In distribution | ||
| 588885 | In distribution | ||
| 67018290 | In distribution | ||
| 598930 | In distribution | ||
| 588878 | In distribution | ||
| SM7460 | In distribution | ||
| 67008200 | In distribution | ||
| 55608000 | In distribution | ||
| 55812600 | In distribution | ||
| 67003700 | In distribution | ||
| 67003800 | In distribution | ||
| SM7647 | 2 | In distribution | |
| 588853 | In distribution | ||
| 55818000 | In distribution | ||
| SM7541 | 2 | In distribution | |
| 588873 | In distribution | ||
| 77818090 | In distribution | ||
| 5888207 | In distribution | ||
| 588815 | In distribution | ||
| 55804200 | In distribution | ||
| 588844 | In distribution | ||
| 588856 | In distribution | ||
| 588875 | In distribution | ||
| 67003400 | In distribution | ||
| 55600400 | In distribution | ||
| 55808400 | In distribution | ||
| SM7662 | 2 | In distribution | |
| 77819190 | In distribution | ||
| 588884 | In distribution | ||
| SM7648 | 2 | In distribution | |
| 588841 | 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 |
|---|---|
| K233637 | 2024-06-28 |
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 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-08-12 | Class II | Error in labeling | Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension. | 1238 units | 2014-09-30 |
| 2004-05-05 | Not classified | Other | The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters. | 40 | 2008-11-21 |
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.