Lifeport
Lifeport Dual Low Profile Plastic Port System with Attachable Dual Lumen 6.6F x 76cm Polyurethane Catheter
2manufacturers in China registered for this device type
8catalogue 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) | K953529 |
| Record published | 2015-09-17 |
| Record revised | 2020-07-27 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Needle gauge 18 G; lumen/inner diameter 1 to 1.6 mm; outer diameter 2.2 to 3.2 mm; length 76 cm; catheter gauge 6.6 to 9.6 Fr |
| Distribution end date | 2021-11-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LPS5057 | Needle Gauge 18 G | In distribution |
| LPS7013 | Outer Diameter 3.2 mm | In distribution |
| LPS5013 | Length 76 cm | In distribution |
| LPS7015 | Lumen/Inner Diameter 1.5 mm | In distribution |
| LPS5513 | Length 76 cm | Withdrawn |
| LPS7513 | Needle Gauge 18 G | Withdrawn |
| LPS7523 | Catheter Gauge 9.6 Fr | Withdrawn |
| LPS7255 | Needle Gauge 18 G | Withdrawn |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 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | 510(k) number | 2004-09-20 | Not classified | Other | The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer. | 44 kits | 2005-03-01 |
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.