Spectrum Vascular
United Statesfrom the FDA registration address FDA FEI 3030714660
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Spectrum Vascular makes
Spectrum Vascular manufactures arterial pressure monitoring sets and trays, central venous catheters including SV Spectrum MRC and MR variants, PICC and midline catheters such as BioFlo and Xcela models with various valve and injection technologies, and intraosseous infusion needles.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Arterial Pressure Monitoring Set/Tray Ref K261455
Regimes: 510(k) Registry: 510(k)Unimpregnated Central Venous Catheter Ref K260165
Regimes: 510(k) Registry: 510(k)Arterial Pressure Monitoring Set/Tray Ref K254278
Regimes: 510(k) Registry: 510(k)SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter Ref K241115
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Intraosseous Infusion Needles Ref K250724
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3030714660
- Address
- 30 Independence Blvd, Suite 120, Warren, NJ, 07059
Frequently asked questions
How many devices does Spectrum Vascular have in the registry?
The registry currently lists 6 devices for Spectrum Vascular. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spectrum Vascular's devices?
Among its 6 most recently registered devices, Spectrum Vascular has devices listed in FDA 510(k) (6 devices).
What risk classes do Spectrum Vascular's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Spectrum Vascular's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spectrum Vascular in the registry?
The most recently registered devices listed for Spectrum Vascular include Arterial Pressure Monitoring Set/Tray, Unimpregnated Central Venous Catheter, SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter and BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology.