Xcela
9.6F x 500mm Xcela Plastic Dual Lumen Power Injectable Port with Pre-Attached Polyurethane Catheter and Silicone Plug
2manufacturers in China registered for this device type
28catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
Record
| Listed by | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | LJT |
| Device type | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5965 |
| 510(k) | K072481 |
| Record published | 2015-09-17 |
| Record revised | 2024-09-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 30 °C |
| Sizes | Outer diameter 2.1 to 3.2 mm; catheter gauge 6 to 9.6 Fr; needle gauge 17 to 18 G; lumen/inner diameter 0.9 to 1.6 mm; length 500 to 750 mm; length 63 cm; pressure 300 psi |
| Distribution end date | 2024-09-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H965451270 | Outer Diameter 2.6 mm | In distribution |
| H965451030 | Length 750 mm | In distribution |
| H965451190 | Needle Gauge 17 G | In distribution |
| H965451090 | Outer Diameter 2.2 mm | In distribution |
| H965451130 | Outer Diameter 2.2 mm | In distribution |
| H965451300 | Length 750 mm | In distribution |
| H965451010 | Lumen/Inner Diameter 1.3 mm | In distribution |
| H965451810 | Needle Gauge 17 G | In distribution |
| H965451820 | Catheter Gauge 9.6 Fr | In distribution |
| H965451830 | Outer Diameter 3.2 mm | In distribution |
| H965451120 | Lumen/Inner Diameter 1.6 mm | In distribution |
| H965451250 | Catheter Gauge 6.6 Fr | In distribution |
| H965451110 | Outer Diameter 2.6 mm | In distribution |
| H965451280 | Length 750 mm | In distribution |
| H965451840 | Lumen/Inner Diameter 0.9 mm | In distribution |
| 44029 | Length 63 cm | Withdrawn |
| 44030 | Pressure 300 psi | Withdrawn |
| H965451170 | Lumen/Inner Diameter 1.3 mm | Withdrawn |
| 44035 | Catheter Gauge 8 Fr | Withdrawn |
| 44038 | Lumen/Inner Diameter 1.3 mm | Withdrawn |
| 44033 | Outer Diameter 2.1 mm | Withdrawn |
| 44040 | Outer Diameter 2.6 mm | Withdrawn |
| 44043 | Lumen/Inner Diameter 1.6 mm | Withdrawn |
| 44031 | Catheter Gauge 8 Fr | Withdrawn |
| 44039 | Outer Diameter 2.6 mm | Withdrawn |
| 44032 | Needle Gauge 18 G | Withdrawn |
| 44037 | Pressure 300 psi | Withdrawn |
| 44041 | Catheter Gauge 6 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dignity® | Medical Components Inc | 168 |
| Deltec | ICU Medical, Inc | 130 |
| NorPort Vascular Access Port | Norfolk Medical | 106 |
| BioFlo Vortex | AngioDynamics, Inc. | 60 |
| BioFlo Vortex | Navilyst Medical, Inc. | 59 |
| Dignity® MID-Sized CT Port | Medical Components Inc | 55 |
| TidalPort Vascular Access Port | Norfolk Medical | 52 |
| Pro-Fuse® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Mini CT Port | Medical Components Inc | 44 |
| Medcomp GEN III Power Injectable Portmedcomp GEN III Power Injectable Port | Medical Components Inc | 29 |
| PRO-Fuse® | Medical Components Inc | 28 |
Showing 12 of 96. All products under Port & Catheter, Implanted, Subcutaneous, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151239 | 2016-06-06 |
| K153228 | 2015-12-04 |
| K131694 | 2013-08-08 |
| K122767 | 2013-04-30 |
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.