FDA.reportPublic FDA data

SPECTRA MEDICAL DEVICES, LLC

Matched from indexed company URL: SPECTRA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12249603000204727SPECTRA MEDICAL DEVICES, LLC1Y2026-01-01299 Ballardvale St Ste 1 WILMINGTON MA US 01887
15287641000136007SPECTRAMED, LLC1N2026-01-01275 W Johnstown Rd Gahanna OH US 43230
96178573000058367Spectral Medical Inc.1N2026-01-01135 The West Mall, Unit 2 TORONTO Ontario CA M9C 1C2
30054620463005462046SPECTRANETICS CORP.1N2026-01-015055 BRANDIN COURT FREMONT CA US 94538
30072840063007284006SPECTRANETICS CORP.1N2026-01-019965 Federal Drive Colorado Springs CO US 80921
30085392453008539245SPECTRA THERAPY LLC1N2026-01-013350 Lapeer Rd Port Huron MI US 48060
30095488403009548840Spectra Baby USA1Y2026-01-013430 Davie Rd. Suite 306 Davie FL US 33314
30110505413011050541SPECTRAL MD, INC.1N2026-01-012515 McKinney Ave Ste 1000 Dallas TX US 75201
30176542473017654247SPECTRAWAVE, INC.1N2026-01-0112 Oak Park Drive Bedford MA US 01730
30304124173030412417SPECTRA RED LIGHT LLC1N2026-01-01531 Maple St Millerstown PA US 17062
30097842803009784280SPECTRANETICS CORP.1N2020-04-256531 Dumbarton Circle Fremont CA US 94555
30114169353011416935SPECTRANETICS CORP.1N2020-04-256655 Wedgwood Road North Suite 105 Maple Grove MN US 55311
30130787503013078750SPECTRA SYMBOL1N2020-04-253101 W 2100 S Salt Lake City UT US 84119

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2246111522896006P960042SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATHMFA1997-12-09
2246111502892847P910001SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEMLPC1993-02-19
2246212044557099P160049STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONONU2017-07-26
2246222044557099P160049STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONONU2017-07-26
2246201235096327P050018ANGIOSCULPT SCORING BALLOON CATHETERNWX2007-01-08
2246111798403434K990713SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTERDRB1999-10-22
155691298660587K971645REGANES SPINAL NEEDLE (VARIOUS)MIA1997-08-01
155691608695873K945965ATRAUMATIC PENCIL POINT SPINAL NEEDLEBSP1995-08-02
155691223470358K891226VASCULAR ACCESS PORT CONTINUOUS INFUSION SETFPA1989-05-30
155691375371123K884792VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLESFMI1989-01-30
155691435579951K880181REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAYCAZ1988-02-11
155691570108064K854816EPIDURAL ANESTHESIA NEEDLESBSP1985-12-19
3034391781284821K253101HyperVue™ Imaging System - IntegratedNQQ2025-12-15
2246111669709004K251358Bridge Plus Occlusion Balloon (590-002)MJN2025-06-24
3034391045591926K251355X1-FFRQHA2025-10-17
3034391838702748K251198HyperVue™ SoftwareNQQ2025-07-16
2246111474511468K250385Turbo-Elite Laser Atherectomy CatheterMCW2025-03-13
3034391635364408K243016Starlight Imaging CatheterNQQ2025-03-20
3034391639363244K230691HyperVue™ Imaging SystemNQQ2023-06-07
2246111271538768K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersMCW2022-12-08
3034391663224876K221257SpectraWAVE Imaging SystemNQQ2023-02-28
2246112049161027K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy SystemMCW2021-06-14
2246111974618367K203540Bridge Occlusion BalloonMJN2020-12-23
179401396612317K183176Endotoxin Activity Assay (EAA)NGS2019-03-12
2246111285971218K182972Phoenix Atherectomy SystemMCW2018-12-20
2246111636344723K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersMCW2018-04-05
2246111906292186K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersMCW2017-11-27
2246111837534181K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy SystemMCW2017-08-24
2246111973813442K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersMCW2017-04-07
155691421779550K163292Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block CrawfordBSP2017-09-08
2246111618755378K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersMCW2017-01-05
2246111594804055K161333TightRail Sub-C Rotating Dilator SheathDRE2016-07-08
2246111176873756K153530Bridge Occlusion BalloonMJN2016-02-05
2246111383490492K152181Turbo-Power Laser Atherectomy CatheterMCW2015-11-12
2246111084096469K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemMCW2015-05-26
155691804111067K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleBSP2016-02-05
2246201427274688K150634AngioSculpt PTA Scoring Baloon CathetersPNO2015-04-08
2246111918271890K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathDRE2015-03-04
2246111242407941K150201Quick-Cross Extreme Support Catheter, Quick-Cross Select Support CatheterDQY2015-02-27
2246111923581339K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support ClipMCW2014-12-19
155691407552940K142791Spectra Soft Tissue Biopsy NeedlesKNW2015-01-21
2246111087530227K142116LLD EZDRB2014-08-12
2246111088493979K141131TIGHTRAIL MINIDRE2014-05-23
2246111867817755K1409441.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIPMCW2014-08-22
2246111615950423K140775TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEMMCW2014-07-23
2246111394774547K140047LEXICONTURE MECHANICAL DILATOR SHEATH SETDRE2014-04-09
2246111376833177K133631LEXIPLIANT DILATOR SHEATH SETDRE2014-03-27
1991351313364863K132832ACTIVAPATCH ET IONTOPHORESIS PATCHEGJ2014-02-13
2246111498845986K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035MCW2013-01-25
2246111975572961K120964UPSTREAM GR CATHETERDQY2012-05-25
465642027211004K120922GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNITIPF2013-02-07
2246111365517418K112887UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTORDYB2012-03-21
2246111195165916K1120328FR TURBO - TANDEM SYSTEMDQY2011-10-17
155691268355923K103740SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULENGT2011-07-29
2246111070003896K094036TURBO-TANDEM SYSTEM MODEL 472-110MCW2010-01-25
2246111670667973K093257TORQMAX SHEATH GRIP ACCESSORYOFC2010-03-26
2246111398980328K092396SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERSDQY2009-09-04
2246111835953734K092378SPECTRANETICS VISISHEATH DILATOR SHEATHDRE2009-11-02
155691612871682K091462SPECTRA MEDICAL SAFETY SCAPELGDZ2009-12-15
1991351031421394K091326ACTIVAPATCHEGJ2009-05-27
155691080824440K082674SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGEFMF2008-11-28
155692002024595K082580SPECTRA GUIDEWIRE INTRODUCER NEEDLEDYB2008-12-08
1887881515890245K080689SPECTRA THERAPY SYSTEM A1000 LASER DEVICEILY2008-07-09
2246111097788854K080144MANDREL GUIDEWIRES OR M-WIRESDQX2008-02-26
2246111943788147K073519QUICKCAT EXTRACTION CATHETER, MODEL 60090-01QEZ2008-03-28
2246111552573170K072750SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066DQY2007-12-04
2246111494339827K071227CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15PDU2007-07-11
2246111200248551K0712268FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043PDU2007-06-29
1991351143138169K061522TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEMEGJ2006-08-01
2246111031587048K060092QUICKCAT EXTRACTION CATHETERQEZ2006-03-09
2246111395671332K060012CLIRPATH TURBO PERIPHERAL CATHETERSPDU2006-09-29
2246111788081296K043401SPECTRANETICS LLD CS, MODEL 518-039DRB2005-03-16
2246111488924645K033678SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038DQY2004-02-23
155691842070445K032196NBD DISPOSABLE RF CANNULAEGXI2003-10-09
465641299021659K023036CARE ETSIPF2003-06-19
2246111742476424K022138SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028DQY2002-09-23
465641328627313K020637SELECT STIMIPF2002-05-28
155691174825291K000117AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLEHEE2000-04-13
1734611325578865DEN250028DeepView AI® SystemSHY2026-05-21
2246111662767128DEN210024CavaClear Laser SheathQRJ2021-12-21
179401438814709DEN030002ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICENGS2003-06-16
2246211454468022
2246111844804412
1887882057776074
155691051749606
155691172485803
3251051192863008
179401200773756
2246111245538456
155691262577788
155691305089280
3034391469298082
155691765623245
3034391827323530
155691844418696
3251051939473704
1734611963322303
155691981479597
3034392060142527

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MCW162025-03-13
DQY72015-02-27
DRE62016-07-08
NQQ52025-12-15
BSP42017-09-08
MJN32025-06-24
DRB32014-08-12
EGJ32014-02-13
IPF32013-02-07
PDU32007-07-11
NGS22019-03-12
ONU22017-07-26
DYB22012-03-21
ILY22008-07-09
QEZ22008-03-28
SHY12026-05-21
QHA12025-10-17
QRJ12021-12-21
PNO12015-04-08
KNW12015-01-21
NGT12011-07-29
OFC12010-03-26
GDZ12009-12-15
FMF12008-11-28
DQX12008-02-26
NWX12007-01-08
GXI12003-10-09
HEE12000-04-13
MFA11997-12-09
MIA11997-08-01
LPC11993-02-19
FPA11989-05-30
FMI11989-01-30
CAZ11988-02-11

NDC#

PMA#

ELCA Coronary Laser Catheters

2022-10-21

SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS117 Date Received09/23/2022 Decision Date10/21/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proces...

ELCA Coronoary Laser Atherectomy Catheter

2022-08-19

SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS116 Date Received06/17/2022 Decision Date08/19/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Pr...

Philips Laser System

2022-05-05

SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS115 Date Received02/23/2022 Decision Date05/05/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Ch...

ELCA Coronary Atherectomy Catheters

2022-02-24

SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS114 Date Received02/14/2022 Decision Date02/24/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement R...

ELCA

2017-07-18

SPECTRANETICS CORP.

200 records. Showing 1-40. Next

PMN#

LLD EZ

2014-08-12

SPECTRANETICS, INC.

99 records. Showing 1-40. Next

Applications#

GUDID#

Smart Line TL Tube Luminometer - Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the <esc> key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actionsperformed and the user prompts.The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.

Spectral Medical Inc

2019-03-14

Sirius 2 Tube Luminometer - The Sirius 2 Tube Luminometer is a highly sensitive and compact stand-alone single tube luminometer. The touchscreen on the control unit is all that is needed to operate the luminometer. Menus and parameters for functions that are not automated, are selected via the touchscreen on the control unit. The display shows the menu items, the actions performed, and the user prompts. The luminometer is capable of reading USB keys. Measurement protocols may be saved on USB keys. During a procedure, the user is prompted step-by-step to place the required tubes into the instrument for measurement. This ensures the standardization of the measurement process. The Sirius 2 is designed for the detection of chemi- and bioluminescence.

Spectral Medical Inc

2025-03-21

80 records. Showing 1-40. Next