Vital-Port
Vital-Port Vascular Access System, Standard Titanium 7.5 Fr, Power Injectable Port
2manufacturers in China registered for this device type
25catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | LJT |
| Device type | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5965 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-24 |
| Record revised | 2019-10-23 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G26504 | In distribution | |
| G26513 | In distribution | |
| G26432 | In distribution | |
| G26439 | In distribution | |
| G26441 | In distribution | |
| G26436 | In distribution | |
| G26449 | In distribution | |
| G26431 | In distribution | |
| G26430 | In distribution | |
| G26435 | In distribution | |
| G26509 | In distribution | |
| G26433 | In distribution | |
| G50863 | In distribution | |
| G26438 | In distribution | |
| G26511 | In distribution | |
| G50860 | In distribution | |
| G26440 | In distribution | |
| G50861 | In distribution | |
| G26502 | In distribution | |
| G26434 | In distribution | |
| G26507 | In distribution | |
| G19803 | In distribution | |
| G26428 | In distribution | |
| G26458 | In distribution | |
| G26437 | In distribution |
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 |
|---|---|
| K150733 | 2015-05-21 |
| K140169 | 2014-05-21 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-10-04 | Not classified | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection | 51,473 total kits/trays | 2011-06-21 |
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.