BioFlo
BioFlo Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Polyurethane Catheter with ENDEXO Technology
2manufacturers in China registered for this device type
14catalogue 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 |
| Record published | 2015-09-14 |
| Record revised | 2024-09-23 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Pressure 300 psi; needle gauge 18 G; catheter gauge 6 to 8 Fr; length 63 cm; outer diameter 2.1 to 2.6 mm; lumen/inner diameter 1.3 to 1.6 mm |
| Distribution end date | 2024-09-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 44013 | Pressure 300 psi | Withdrawn |
| 44011 | Length 63 cm | Withdrawn |
| 44020 | Catheter Gauge 6 Fr | Withdrawn |
| 44017 | Length 63 cm | Withdrawn |
| 44021 | Lumen/Inner Diameter 1.6 mm | Withdrawn |
| 44012 | Catheter Gauge 6 Fr | Withdrawn |
| 44019 | Pressure 300 psi | Withdrawn |
| 44015 | Pressure 300 psi | Withdrawn |
| 44014 | Pressure 300 psi | Withdrawn |
| 44023 | Catheter Gauge 6 Fr | Withdrawn |
| 44025 | Catheter Gauge 8 Fr | Withdrawn |
| 44027 | Catheter Gauge 8 Fr | Withdrawn |
| 44028 | Catheter Gauge 8 Fr | Withdrawn |
| 44022 | Outer Diameter 2.6 mm | Withdrawn |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.