Pristine
Pristine Long-Term Hemodialysis Catheter, 55 cm
2manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
30recalls on this code
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Bard Peripheral Vascular, Inc., United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2021-04-14 |
Specifications
| MRI safety | MR Safe |
|---|---|
| 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 |
| Packaging | Case of 5 |
| Sizes | Length 19 to 55 cm; catheter gauge 15.5 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5403550 | Length 55 cm | In distribution |
| 5403330 | Catheter Gauge 15.5 Fr | In distribution |
| 5403230 | Length 23 cm | In distribution |
| 5403190 | Catheter Gauge 15.5 Fr | In distribution |
| 5403280 | Catheter Gauge 15.5 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 406 |
| Split Cath® III | Medical Components Inc | 277 |
| Palindrome | Mozarc Medical US LLC | 139 |
| Titan HD | Medical Components Inc | 75 |
| ProGuide™ | Merit Medical Systems, Inc. | 72 |
| Hemo-Flow® | Medical Components Inc | 65 |
| DuraMax® | Merit Medical Systems, Inc. | 55 |
| CentrosFLO® | Merit Medical Systems, Inc. | 51 |
| BioFlo DuraMax® | Merit Medical Systems, Inc. | 51 |
| BioFlo | Navilyst Medical, Inc. | 45 |
| DuraFlow | AngioDynamics, Inc. | 37 |
| Mahurkar | Mozarc Medical US LLC | 37 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211410 | 2021-06-04 |
Recalls
30 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 |
|---|---|---|---|---|---|
| 2019-06-14 | Class II | Error in labeling | Incorrect Peel-Apart Introducer Sheath in Kit. | 215 | 2024-09-18 |
| 2019-06-14 | Class II | Error in labeling | Incorrect Peel-Apart Introducer Sheath in Kit. | 400 | 2024-09-18 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 2 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 455 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 39 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 2,298 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 34 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 135 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 713 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 100 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 39 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 104 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 46 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 1731 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 161 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 240 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 1,114 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 899 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 140 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 91 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 1,679 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 887 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 10,507 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 13 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 570 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 309 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 1356 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 0 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 40 units | 2022-05-17 |
| 2019-05-31 | Class II | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | 7,070 units | 2022-05-17 |
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.