Zurpaz™ Steerable Sheath Set
Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath
13manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Creganna Unlimited Company |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| 510(k) | K131079 |
| Record published | 2016-09-23 |
| Record revised | 2021-12-22 (version 7) |
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 |
| Sizes | Catheter gauge 8.5 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M004JPNMC85500 | Catheter Gauge 8.5 Fr | In distribution |
| M004EPTMC85300 | Catheter Gauge 8.5 Fr | In distribution |
| M004JPNMCA85600 | Catheter Gauge 8.5 Fr | In distribution |
| M004EPTMCA85400 | Catheter Gauge 8.5 Fr | In distribution |
| M004USMCA85200 | Catheter Gauge 8.5 Fr | In distribution |
| M004USMC85100 | Catheter Gauge 8.5 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Creganna Medical Ireland Limited | 510(k) number | 2017-05-22 | Class II | Packaging | Lack of sterility assurance. | 85 units | 2018-05-29 |
| Creganna Medical Ireland Limited | 510(k) number | 2017-05-22 | Class II | Packaging | Lack of sterility assurance. | 150 units | 2018-05-29 |
| Creganna Medical Ireland Limited | 510(k) number | 2017-05-22 | Class II | Packaging | Lack of sterility assurance. | 100 uniits | 2018-05-29 |
| Creganna Medical Ireland Limited | 510(k) number | 2017-05-22 | Class II | Packaging | Lack of sterility assurance. | 50 units | 2018-05-29 |
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.