Data / Medical devices / United States / Spectrum Vascular
Spectrum Vascular: FDA-registered device maker in Warren, NJ, United States, 20 510(k) clearances
Spectrum Vascular is registered with the FDA (registration 3030714660) in Warren, NJ, United States. It lists 8 device types. The FDA files 20 510(k) clearances under its listings, the newest dated December 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030714660
- Address
- 30 Independence Blvd, Suite 120, Warren, NJ, United States, 07059
- Owner or operator
- Spectrum Vascular (10090343)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 14, 2024
- Registered through
- 2026
- Brand names listed
- Arterial Pressure Monitoring Set/Tray, BIOFLO HYBRID PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY, BIOFLO MIDLINE CATHETER, BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY, BIOFLO PICC WITH ENDEXO TECHNOLOGY, BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit, BioFlo Midline with ENDEXO Technology, BioFlo PICC with ENDEXO Technology - Maximal Barrier Nursing Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Embolectomy | DXE | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) | NHC | 2 | Specification developer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Specification developer | accessdata.fda.gov |
| Midline Catheter | PND | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2025 | K252373 | 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 | LJS | Substantially Equivalent | Spectrum Vascular | accessdata.fda.gov |
| July 30, 2025 | K250724 | Intraosseous Infusion Needles | FMI | Substantially Equivalent | Spectrum Vascular | accessdata.fda.gov |
| May 17, 2019 | K182252 | Cook Unimpregnated Central Venous Catheter | FOZ | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 19, 2018 | K180846 | Arterial Pressure Monitoring Set/Tray | DQO | Unknown | Cook Incorporated | accessdata.fda.gov |
| November 30, 2018 | K180792 | Arterial Pressure Monitoring Set/Tray | DQO | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 12, 2018 | K180567 | C3 Wave System | LJS | Substantially Equivalent | Medical Components, Inc. (dba MedComp) | accessdata.fda.gov |
| July 27, 2017 | K163031 | Bunegin-Albin Air Aspiration Set | DXE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 3, 2017 | K163452 | PICC Maximal Barrier Nursing Kit | LJS | Unknown | Navilyst Medical, Inc. | accessdata.fda.gov |
| September 8, 2016 | K161866 | BioFlo Midline Catheter | FOZ | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| July 26, 2016 | K160887 | Cook Intraosseous Infusion Needles | FMI | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 8, 2016 | K160223 | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter | NHC | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 24, 2015 | K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC | LJS | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| March 19, 2015 | K150448 | NMI PICC III and NMI PICC IV | LJS | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| January 27, 2015 | K142889 | Celerity PICC Tip Confirmation System | LJS | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| August 23, 2012 | K121089 | NMI PICC III | LJS | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| August 3, 2012 | K121990 | PICC CONVENIENCE KIT | LJS | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| July 30, 2008 | K081113 | COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS | FOZ | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| August 12, 2004 | K033843 | SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING | FOZ | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| May 30, 2003 | K021557 | SPECTRUM SILICONE CATHETER | FOZ | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| October 18, 1996 | K963097 | CLAMPLESS VALVED CATHETER-PICC (CVC-PICC) | LJS | Substantially Equivalent | Bmw Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Embolectomy
- All makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Midline Catheter
Updated December 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.