SPECTRUM VASCULAR
Matched from indexed company URL: Spectrum Vascular
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|
| 3030714660 | 3030714660 | SPECTRUM VASCULAR | 1 | N | 2026-01-01 | 50 Main St. Suite 1000 White Plains NY US 10606 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|
| 326895 | 1885000864 | K963097 | CLAMPLESS VALVED CATHETER-PICC (CVC-PICC) | LJS | 1996-10-18 |
| 326895 | 1117167607 | 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 | 2025-12-16 |
| 326895 | 1693824114 | K250724 | Intraosseous Infusion Needles | FMI | 2025-07-30 |
| 326895 | 1545658736 | K182252 | Cook Unimpregnated Central Venous Catheter | FOZ | 2019-05-17 |
| 326895 | 1540934893 | K180846 | Arterial Pressure Monitoring Set/Tray | DQO | 2018-12-19 |
| 326895 | 1784324515 | K180792 | Arterial Pressure Monitoring Set/Tray | DQO | 2018-11-30 |
| 326895 | 1845618347 | K180567 | C3 Wave System | LJS | 2018-04-12 |
| 326895 | 1377134832 | K163452 | PICC Maximal Barrier Nursing Kit | LJS | 2017-02-03 |
| 326895 | 1624801510 | K163031 | Bunegin-Albin Air Aspiration Set | DXE | 2017-07-27 |
| 326895 | 1842016678 | K161866 | BioFlo Midline Catheter | FOZ | 2016-09-08 |
| 326895 | 1685445116 | K160887 | Cook Intraosseous Infusion Needles | FMI | 2016-07-26 |
| 326895 | 1303970355 | K160223 | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter | NHC | 2016-04-08 |
| 326895 | 1082919192 | K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC | LJS | 2015-09-24 |
| 326895 | 2063036917 | K150448 | NMI PICC III and NMI PICC IV | LJS | 2015-03-19 |
| 326895 | 1138554533 | K142889 | Celerity PICC Tip Confirmation System | LJS | 2015-01-27 |
| 326895 | 1171108722 | K121990 | PICC CONVENIENCE KIT | LJS | 2012-08-03 |
| 326895 | 1070666932 | K121089 | NMI PICC III | LJS | 2012-08-23 |
| 326895 | 1241265743 | K081113 | COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS | FOZ | 2008-07-30 |
| 326895 | 1322097947 | K033843 | SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING | FOZ | 2004-08-12 |
| 326895 | 1306435596 | K021557 | SPECTRUM SILICONE CATHETER | FOZ | 2003-05-30 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|
| LJS | 9 | 2025-12-16 |
| FOZ | 5 | 2019-05-17 |
| FMI | 2 | 2025-07-30 |
| DQO | 2 | 2018-12-19 |
| DXE | 1 | 2017-07-27 |
| NHC | 1 | 2016-04-08 |