Vaxcel
14.5F x 28cm Vaxcel Plus Chronic Dialysis Catheter with Plastic Tunneler and 3 Introducer Needle Sizes
2manufacturers in China registered for this device type
22catalogue numbers in this listing
1510(k) clearance
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 | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Record published | 2015-10-19 |
| Record revised | 2021-11-03 (version 4) |
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 | Outer diameter 4.8 mm; length 19 to 50 cm; catheter gauge 14.5 Fr; length 9 in |
| Distribution end date | 2021-11-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45554 | Outer Diameter 4.8 mm | Withdrawn |
| 45551 | Catheter Gauge 14.5 Fr | Withdrawn |
| 45549 | Catheter Gauge 14.5 Fr | Withdrawn |
| 45556 | Length 50 cm | Withdrawn |
| 45583 | Length 9 in | Withdrawn |
| 45540 | Catheter Gauge 14.5 Fr | Withdrawn |
| 45541 | Catheter Gauge 14.5 Fr | Withdrawn |
| 45552 | Outer Diameter 4.8 mm | Withdrawn |
| 45550 | Outer Diameter 4.8 mm | Withdrawn |
| 45584 | Length 9 in | Withdrawn |
| 45543 | Outer Diameter 4.8 mm | Withdrawn |
| 45542 | Outer Diameter 4.8 mm | Withdrawn |
| 45544 | Length 23 cm | Withdrawn |
| 45559 | Length 50 cm | Withdrawn |
| 45558 | Outer Diameter 4.8 mm | Withdrawn |
| 45555 | Catheter Gauge 14.5 Fr | Withdrawn |
| 45557 | Catheter Gauge 14.5 Fr | Withdrawn |
| 45545 | Catheter Gauge 14.5 Fr | Withdrawn |
| 45546 | Outer Diameter 4.8 mm | Withdrawn |
| 45553 | Catheter Gauge 14.5 Fr | Withdrawn |
| 45547 | Catheter Gauge 14.5 Fr | Withdrawn |
| 45548 | Length 28 cm | Withdrawn |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 |
| Mahurkar | Mozarc Medical US LLC | 37 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131260 | 2014-02-14 |
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.