PowerPort M.R.I.
PowerPort M.R.I. Implantable Port with Suture Plugs with Attachable 9.6F Silicone, Open-Ended Single-Lumen Venous Catheter. Peel-Apart Introducer Kit and 5F MicroIntroducer Kit
2manufacturers in China registered for this device type
9catalogue numbers in this listing
6510(k) clearances naming this product code
4recalls on this 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 | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | LJT |
| Device type | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5965 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-05-29 |
| Record revised | 2024-08-28 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 |
| Packaging | Case of 5 |
| Sizes | Length 45 cm; catheter gauge 9.6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1859600 | Length 45 cm | In distribution |
| 1859661 | Catheter Gauge 9.6 Fr | In distribution |
| 1809660 | Length 45 cm | In distribution |
| 1859601 | Length 45 cm | In distribution |
| 1809601 | Length 45 cm | In distribution |
| 1809661 | Length 45 cm | In distribution |
| 1809600 | Length 45 cm | In distribution |
| 1859660 | Length 45 cm | In distribution |
| 1809670 | Catheter Gauge 9.6 Fr | 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 |
|---|---|
| K252478 | 2025-09-05 |
| K251253 | 2025-06-18 |
| K242328 | 2024-10-31 |
| K050310 | 2005-04-18 |
| K926139 | 1995-01-03 |
| K924250 | 1993-10-04 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-08-08 | Class II | Nonconforming Material/Component | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), Power | 16,410 units | 2015-08-05 |
| 2014-02-27 | Class II | Packaging | Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture pl | 777 | 2014-09-05 |
| 2012-02-16 | Not classified | Labeling Change Control | The end flap label on the kit incorrectly describes the product as “Bard Port” MRI DUAL Implanted Port instead of a “Bard Port MRI Implanted Port” as correctly indicated on the main label of the kit. | 545 units (Lot RESF0856 – 150 units; Lot RESH0067 – 295 unit | 2012-03-30 |
| 2010-03-18 | Not classified | Mixed-up of materials/components | 8F PowerPort stems were mixed with 6F PowerPorts and packaged. | 200 units total (100 units of each lot, see code information | 2010-10-01 |
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.