Spectrum Vascular
Warren, NJ, US
SPECTRUM VASCULAR appears in FDA device records in Warren, NJ. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Spectrum Vascular between 2024 and 2026. The busiest year on record is 2026, with 3. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260165 | Unimpregnated Central Venous Catheter | FOZ | Substantially Equivalent | |
| K261455 | Arterial Pressure Monitoring Set/Tray | DQO | Substantially Equivalent | |
| K254278 | Arterial Pressure Monitoring Set/Tray | DQO | Substantially Equivalent | |
| 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 | |
| K250724 | Intraosseous Infusion Needles | FMI | Substantially Equivalent | |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter | FOZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3030714660 | 3030714660 | SPECTRUM VASCULAR | 30 Independence Blvd, Suite 120, Warren, NJ 07059 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DXECatheter, Embolectomy
- DQOCatheter, Intravascular, Diagnostic
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- NHCCatheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
- DREDilator, Vessel, For Percutaneous Catheterization
- PNDMidline Catheter
- FMINeedle, Hypodermic, Single Lumen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain