Amecath Twincath Catheter
Permthane Twin Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 27 Cm total length 32 Cm
2manufacturers in China registered for this device type
29catalogue numbers in this listing
2510(k) clearances naming this product 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 | Ameco Medical Industries, Egypt |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K131814 |
| Record published | 2014-07-31 |
| Record revised | 2021-02-05 (version 4) |
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, manufacturing date |
| Sizes | Length 10 to 50 cm; catheter gauge 8 to 15.5 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P2TC-0812-KPC | Length 12 cm | In distribution |
| P2TC-1219-K | Catheter Gauge 12 Fr | In distribution |
| P2TC-1015-KPC | Length 15 cm | In distribution |
| P2TC-1012-KPC | Catheter Gauge 10 Fr | In distribution |
| P2TC-1450-K | Catheter Gauge 14 Fr | In distribution |
| P2TC-0810-KPC | Catheter Gauge 8 Fr | In distribution |
| P2TC-15.527-KPC | Length 27 cm | In distribution |
| P2TC-1435-K | Length 35 cm | In distribution |
| P2TC-1216-KPC | Catheter Gauge 12 Fr | In distribution |
| P2TC-15.527-K | Catheter Gauge 15.5 Fr | In distribution |
| P2TC-1431-K | Catheter Gauge 14 Fr | In distribution |
| P2TC-15.523-K | Length 23 cm | In distribution |
| P2TC-1427-KPC | Catheter Gauge 14 Fr | In distribution |
| P2TC-15.535-KPC | Length 35 cm | In distribution |
| P2TC-15.531-K | Length 31 cm | In distribution |
| P2TC-1431-KPC | Length 31 cm | In distribution |
| P2TC-1216-K | Length 16 cm | In distribution |
| P2TC-15.519-K | Catheter Gauge 15.5 Fr | In distribution |
| P2TC-1423-KPC | Length 23 cm | In distribution |
| P2TC-1219-KPC | Length 19 cm | In distribution |
| P2TC-15.535-K | Catheter Gauge 15.5 Fr | In distribution |
| P2TC-15.523-KPC | Catheter Gauge 15.5 Fr | In distribution |
| P2TC-1423-K | Catheter Gauge 14 Fr | In distribution |
| P2TC-1450-KPC | Length 50 cm | In distribution |
| P2TC-1419-KPC | Length 19 cm | In distribution |
| P2TC-1419-K | Catheter Gauge 14 Fr | In distribution |
| P2TC-15.531-KPC | Catheter Gauge 15.5 Fr | In distribution |
| P2TC-15.519-KPC | Length 19 cm | In distribution |
| P2TC-1435-KPC | Catheter Gauge 14 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 |
|---|---|
| K131814 | 2013-07-26 |
| K123943 | 2013-04-02 |
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.