Envoy
ENVOY XB Guiding Catheter CBL MOD (BURKE) 100 cm 7F (2.3 mm) .078 Inch (2.0 mm)
14manufacturers in China registered for this device type
57catalogue numbers in this listing
24recalls 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 | Cerenovus, Inc., 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) | K093184 |
| Record published | 2016-06-30 |
| Record revised | 2025-07-14 (version 12) |
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 | Storage environment temperature up to 130 °F; Storage environment temperature up to 54 °C; Handling environment temperature up to 54 °C; Handling environment temperature up to 130 °F; Special storage condition: STORE IN A COOL, DARK, DRY PLACE |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 670-258-90B | In distribution | |
| 778-252-00 | In distribution | |
| 670-252-00B | In distribution | |
| 670-254-90 | In distribution | |
| 670-250-90B | In distribution | |
| 778-252-90B | In distribution | |
| 778-252-90 | In distribution | |
| 778-256-90B | In distribution | |
| 778-260-90B | In distribution | |
| 670-260-00B | In distribution | |
| 778-254-90 | In distribution | |
| 670-250-90 | In distribution | |
| 778-248-00B | In distribution | |
| 556-260-90 | In distribution | |
| 778-254-00 | In distribution | |
| 556-254-90 | In distribution | |
| 670-252-90 | In distribution | |
| 556-260-00 | In distribution | |
| 670-250-00B | In distribution | |
| 778-254-90B | In distribution | |
| 670-250-00 | In distribution | |
| 778-260-90 | In distribution | |
| 778-248-00 | In distribution | |
| 670-258-90 | In distribution | |
| 670-256-00B | In distribution | |
| 670-260-00 | In distribution | |
| 556-254-00 | In distribution | |
| 670-254-00B | In distribution | |
| 778-258-90B | In distribution | |
| 670-254-00 | In distribution | |
| 556-258-00 | In distribution | |
| 778-248-90 | In distribution | |
| 556-250-00 | In distribution | |
| 556-258-90 | In distribution | |
| 670-258-00 | In distribution | |
| 670-256-90B | In distribution | |
| 670-258-00B | In distribution | |
| 670-256-90 | In distribution | |
| 778-254-00B | In distribution | |
| 778-248-90B | In distribution | |
| 670-256-00 | In distribution | |
| 778-260-00 | In distribution | |
| 556-256-00 | In distribution | |
| 778-258-90 | In distribution | |
| 670-252-00 | In distribution | |
| 778-252-00B | In distribution | |
| 778-256-90 | In distribution | |
| 778-256-00B | In distribution | |
| 556-256-90 | In distribution | |
| 778-256-00 | In distribution | |
| 670-260-90 | In distribution | |
| 556-250-90 | In distribution | |
| 670-254-90B | In distribution | |
| 778-260-00B | In distribution | |
| 670-252-90B | In distribution | |
| 670-260-90B | In distribution | |
| 778-258-00 | 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
Recalls
24 of these are 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 |
|---|---|---|---|---|---|
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 32 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 34 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 5 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 129 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 522 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 25 | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 1548 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 202 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 50 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 56 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 10 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of packaging integrity | 867 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 46 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 268 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 46 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 867 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 64 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 266 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 5 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 273 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 19 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 202 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 141 units | 2015-08-10 |
| 2013-01-11 | Class II | Component design/selection | Sterility of device may be compromised due to lack of package integrity | 234 units | 2015-08-10 |
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.