FDA.reportPublic FDA data

NORTHEAST SCIENTIFIC, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30054671443005467144NORTHEAST SCIENTIFIC, INC.1N2026-01-012142 Thomaston Ave Waterbury CT US 06704

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
659821883388139K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)OWQ2025-05-12
659821181752975K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterOWQ2023-02-03
659821613194137K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterQTF2022-07-01
659821893780938K200195NES Reprocessed Visions PV .014P RX Digital IVUS CatheterOBJ2020-06-22
659821044605769K181126Reprocessed Visions PV .035 Digital IVUS CatheterOWQ2019-01-18
659821627825061K173214NES Reprocessed RF Stylet (RFS)NUJ2018-03-27
659821513941127K090661NES REPROCESSED VARICOSE VEIN RF CATHETERNUJ2010-07-21
659821513755679
659821667372929
659821837165734
659821937935337

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWQ32025-05-12
NUJ22018-03-27
QTF12022-07-01
OBJ12020-06-22

PMN#