Navilyst Medical, Inc.
20 product lines across 7 device categories: Biliary drains, Guidewires, Implanted ports, Nephrostomy catheters, PICC lines, Tunneled central lines.
Biliary Drainage Catheters
Used in: Percutaneous Biliary Drainage (PTBD)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Exodus Array Multipurpose Drainage Catheter 8F x 35cm with Tight Pigtail | Length: 15–35 cm; Catheter Gauge: 6–14 Fr; Outer Diameter: 2.1–4.7 mm | 50 | Not stated |
Guidewires
Used in: Uterine Artery Embolization (UAE), Peripheral Balloon Angioplasty, Stroke Thrombectomy, Internal Iliac Artery Embolization
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Navilyst Angiographic Guidewire, Fixed Core, J/Straight Tip | Outer Diameter: 0.02–0.04 in; Length: 60–260 cm; Length: 150 Feet | 51 | Not stated |
| Navylist GUIDEWIRE, 1.5MM J-.038-150-ROSEN-PTFE | Length: 80–150 cm; Outer Diameter: 0.04–0.04 in | 3 | Not stated |
Implanted Ports (Port-a-Cath)
Used in: Port-a-Cath (Implanted Port) Placement
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| BioFlo Vortex Smart Plastic Low Profile Port with Endexo and Vortex Technology | Length: 45–63 cm; Outer Diameter: 1.8–2.67 mm; Catheter Gauge: 5–8 Fr | 59 | MR Conditional |
| Xcela 8F x 750mm Xcela Low Profile Titanium Power Injectable Port | Lumen/Inner Diameter: 0.9–1.6 mm; Outer Diameter: 2.1–3.2 mm; Needle Gauge: 17–18 G | 28 | Not stated |
| Vortex Vortex LP Single Plastic Port System with Attachable 9.6F x 76cm Silicone Catheter | Length: 53–76 cm; Needle Gauge: 18 G; Outer Diameter: 1.7–3.8 mm | 25 | MR Conditional |
| BioFlo BioFlo Dual Port with Endexo Technology - Plastic Port with Non-Filled Suture Holes and 8F Polyurethane Catheter | Catheter Gauge: 6–8 Fr; Outer Diameter: 2.1–2.6 mm; Pressure: 300 Pound per Square Inch | 14 | MR Conditional |
| Lifeport Lifeport Low Profile Titanium Port System with Detached 8.4F/9.6F x 76cm Silicone Catheter | Needle Gauge: 18 G; Lumen/Inner Diameter: 1–1.6 mm; Outer Diameter: 2.2–3.2 mm | 8 | MR Conditional |
| Vaxcel Vaxcel Titanium Standard Port with PASV Valve and 8F x 63cm Silicone Catheter | Length: 63 cm; Needle Gauge: 18 G; Outer Diameter: 1.9–2.6 mm | 7 | MR Conditional |
Nephrostomy and Nephroureteral Catheters
Used in: Nephrostomy Tube Placement, Nephroureteral Stent (PCNU) Placement
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Exodus 8F x 25cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating | Catheter Gauge: 8–14 Fr; Outer Diameter: 2.7–4.7 mm; Length: 20–35 cm | 9 | Not stated |
PICC Lines and Midline Catheters
Used in: PICC Line Placement
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| BioFlo BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit | Catheter Gauge: 3–6 Fr; Length: 20–55 cm; Outer Diameter: 1.02–2.2 mm | 684 | Not stated |
| Xcela PICC Convenience Kit | Length: 45–55 cm; Catheter Gauge: 3–6 Fr; Outer Diameter: 1.05–2.2 mm | 270 | Not stated |
| Vaxcel PICC Convenience Kit | Catheter Gauge: 3–6 Fr; Length: 55–60 cm; Outer Diameter: 1.02–1.95 mm | 48 | Not stated |
| Navilyst Medical PICC Convenience Kit | Length: 55 cm; Catheter Gauge: 4–5 Fr | 3 | Not stated |
| Xcela; BioFlo; Vaxcel PICC Convenience Kit | Catheter Gauge: 4 Fr; Length: 55 cm | 2 | Not stated |
| Celerity Celerity PICC Tip Confirmation System | — | 1 | Not stated |
Tunneled Central Venous Catheters (Broviac, Hickman)
Used in: Tunneled Central Line (Broviac or Hickman) Placement
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| BioFlo Bio-Stable 5F SL-55CM Catheter Kit Non-Valved | Length: 20–55 cm; Outer Diameter: 1.02–1.73 mm; Catheter Gauge: 3–5 Fr | 10 | Not stated |
| Celerity Celerity Remote Control Cable Accessory | — | 4 | Not stated |
Tunneled Dialysis Catheters (Permcath)
Used in: Tunneled Dialysis Catheter (Permcath) Placement
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| BioFlo 15.5Fx20cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit | Catheter Gauge: 15.5 Fr; Length: 20–55 cm; Outer Diameter: 5.2 mm | 45 | Not stated |
| Vaxcel 14.5F x 50cm Vaxcel Plus Chronic Dialysis Catheter with Plastic Tunneler | Catheter Gauge: 14.5 Fr; Outer Diameter: 4.8 mm; Length: 19–50 cm | 22 | Not stated |
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Product lines, models and sizes are compiled from the FDA Global Unique Device Identification Database (GUDID) and FDA clearance records. Descriptions marked "Provided by the manufacturer" come from the company and are reviewed before publishing.