FDA.report

SPECTRUM VASCULAR

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30307146603030714660SPECTRUM VASCULAR1N2026-01-0150 Main St. Suite 1000 White Plains NY US 10606

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3268951885000864K963097CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)LJS1996-10-18
3268951117167607K252373BioFlo 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 TechnologyLJS2025-12-16
3268951693824114K250724Intraosseous Infusion NeedlesFMI2025-07-30
3268951545658736K182252Cook Unimpregnated Central Venous CatheterFOZ2019-05-17
3268951540934893K180846Arterial Pressure Monitoring Set/TrayDQO2018-12-19
3268951784324515K180792Arterial Pressure Monitoring Set/TrayDQO2018-11-30
3268951845618347K180567C3 Wave SystemLJS2018-04-12
3268951377134832K163452PICC Maximal Barrier Nursing KitLJS2017-02-03
3268951624801510K163031Bunegin-Albin Air Aspiration SetDXE2017-07-27
3268951842016678K161866BioFlo Midline CatheterFOZ2016-09-08
3268951685445116K160887Cook Intraosseous Infusion NeedlesFMI2016-07-26
3268951303970355K160223VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage CatheterNHC2016-04-08
3268951082919192K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCLJS2015-09-24
3268952063036917K150448NMI PICC III and NMI PICC IVLJS2015-03-19
3268951138554533K142889Celerity PICC Tip Confirmation SystemLJS2015-01-27
3268951171108722K121990PICC CONVENIENCE KITLJS2012-08-03
3268951070666932K121089NMI PICC IIILJS2012-08-23
3268951241265743K081113COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERSFOZ2008-07-30
3268951322097947K033843SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATINGFOZ2004-08-12
3268951306435596K021557SPECTRUM SILICONE CATHETERFOZ2003-05-30

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LJS92025-12-16
FOZ52019-05-17
FMI22025-07-30
DQO22018-12-19
DXE12017-07-27
NHC12016-04-08

PMN