Mahurkar
Chronic Carbothane Catheter Tray,Staggered Tip with Sideholes and Tal Venatrac Stylet,14.5 Fr/Ch (4.8 mm) x 23 cm
2manufacturers in China registered for this device type
37catalogue numbers in this listing
5recalls 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 | Mozarc Medical US LLC, United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K111372 |
| Record published | 2015-10-22 |
| Record revised | 2025-12-02 (version 10) |
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 | Handling environment temperature 59 to 86 °F |
| Packaging | Pack_or_inner_pack of 5, case of 24 |
| Sizes | Length 19 to 50 cm; catheter gauge 13.5 to 14.5 Fr |
| Distribution end date | 2021-08-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8888123435 | Length 23 cm | In distribution |
| 8888119385 | Length 19 cm | In distribution |
| 8888145004 | Length 33 cm | In distribution |
| 8833074001 | Length 36 cm | In distribution |
| 8888145029 | Length 28 cm | In distribution |
| 8888145252 | Length 23 cm | In distribution |
| 8833074003 | Length 45 cm | In distribution |
| 8888128485 | Length 28 cm | In distribution |
| 8888145254 | Length 33 cm | In distribution |
| 8888145251 | Length 19 cm | In distribution |
| 8888145001 | Length 19 cm | In distribution |
| 8888145028 | Length 23 cm | In distribution |
| 8888145002 | Length 23 cm | In distribution |
| 8888128452 | Length 28 cm | In distribution |
| 8888119362 | Length 19 cm | In distribution |
| 8888145003 | Length 28 cm | In distribution |
| 8888133535 | Length 33 cm | In distribution |
| 8888123402 | Length 23 cm | In distribution |
| 8888133502 | Length 33 cm | In distribution |
| 8833074004 | Length 50 cm | In distribution |
| 8833074002 | Length 40 cm | In distribution |
| 8888145030 | Length 33 cm | In distribution |
| 8888145027 | Length 19 cm | In distribution |
| 8888145253 | Length 28 cm | In distribution |
| 8888145032 | Length 23 cm | Withdrawn |
| 8888145034 | Length 33 cm | Withdrawn |
| 8888145256 | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888123430 | Length 23 cm | Withdrawn |
| 8833052003 | Catheter Gauge 13.5 Fr | Withdrawn |
| 8888145033 | Length 28 cm | Withdrawn |
| 8833052002 | Length 23 cm | Withdrawn |
| 8888145031 | Length 19 cm | Withdrawn |
| 8888145257 | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888145258 | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888128480 | Length 28 cm | Withdrawn |
| 8888145255 | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888119380 | Length 19 cm | Withdrawn |
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 |
| HemoSplit Long-Term Hemodialysis Catheter | Bard Access Systems, Inc. | 35 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
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 |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2023-08-22 | Class II | Under Investigation by firm | Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body. | 3050 devices |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 576,018 units |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 132,443 units |
Recalls
5 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 |
|---|---|---|---|---|
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
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.