Quick-Cross™Extreme™
Quick-Cross™Extreme™ Support Catheter
14manufacturers in China registered for this device type
18catalogue numbers in this listing
11510(k) clearances naming this product code
8recalls 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 | Spectranetics 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 |
| 510(k) | K092396 |
| Record published | 2015-02-06 |
| Record revised | 2021-12-22 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry; Storage environment temperature up to 131 °F |
| Packaging | Box of 5 |
| Sizes | Length 65 to 150 cm |
| Distribution end date | 2019-02-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 518-084AA | Length 135 cm | In distribution |
| 518-088AA | Length 90 cm | In distribution |
| 518-086AA | Length 150 cm | In distribution |
| 518-080AA | Length 135 cm | In distribution |
| 518-082AA | Length 150 cm | In distribution |
| 518-078AA | Length 90 cm | In distribution |
| 518-090AA | Length 135 cm | In distribution |
| 518-076AA | Length 65 cm | In distribution |
| 518-092AA | Length 150 cm | In distribution |
| 518-090 | Length 135 cm | Withdrawn |
| 518-078 | Length 90 cm | Withdrawn |
| 518-086 | Length 150 cm | Withdrawn |
| 518-082 | Length 150 cm | Withdrawn |
| 518-092 | Length 150 cm | Withdrawn |
| 518-088 | Length 90 cm | Withdrawn |
| 518-084 | Length 135 cm | Withdrawn |
| 518-076 | Length 65 cm | Withdrawn |
| 518-080 | Length 135 cm | 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 |
|---|---|
| K150201 | 2015-02-27 |
| K112032 | 2011-10-17 |
| K092396 | 2009-09-04 |
| K091299 | 2009-07-01 |
| K090913 | 2009-05-04 |
| K082559 | 2008-12-11 |
| K082561 | 2008-12-10 |
| K072750 | 2007-12-04 |
| K033678 | 2004-02-23 |
| K022138 | 2002-09-23 |
| K991059 | 1999-11-16 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-07-18 | Not classified | Package design/selection | Packaging integrity may be compromised, thus sterility can not be assured. | 123 units | 2011-08-12 |
| 2011-07-18 | Not classified | Package design/selection | Packaging integrity may be compromised, thus sterility can not be assured. | 57 units | 2011-08-12 |
| 2010-11-16 | Not classified | Device Design | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. | 17682 total units, all sizes and lots | 2011-10-04 |
| 2010-11-16 | Not classified | Device Design | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. | 17682 units, all sizes and lots | 2011-10-04 |
| 2010-11-16 | Not classified | Device Design | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. | 17682 units, all sizes and lots | 2011-10-04 |
| 2010-11-16 | Not classified | Device Design | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. | 17682 units, all sizes and lots | 2011-10-04 |
| 2010-11-16 | Not classified | Device Design | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. | 17682 units, all sizes and lots | 2011-10-04 |
| 2007-12-10 | Not classified | Packaging process control | Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm–the exterior box labeling is correct as 90 cm. | 64 | 2008-02-08 |
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.