FDA.report

SPECTRANETICS CORP.

Matched from indexed company URL: Spectranetics Corp.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30054620463005462046SPECTRANETICS CORP.1N2026-01-015055 BRANDIN COURT FREMONT CA US 94538
30072840063007284006SPECTRANETICS CORP.1N2026-01-019965 Federal Drive Colorado Springs CO US 80921
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

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00813132029937CVX-300 - Excimer Laser System1-800-633-0960complaints@spnc.com
00813132029944Turbo-Power - Turbo-Power Laser Atherectomy Catheter, 2.0mm1-800-633-0960SPNC-complaints@philips.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2246111522896006P960042SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATHMFA1997-12-09
2246111502892847P910001SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEMLPC1993-02-19
2246222044557099P160049STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONONU2017-07-26
2246212044557099P160049STELLAREX 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
2246111669709004K251358Bridge Plus Occlusion Balloon (590-002)MJN2025-06-24
2246111474511468K250385Turbo-Elite Laser Atherectomy CatheterMCW2025-03-13
2246111271538768K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersMCW2022-12-08
2246112049161027K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy SystemMCW2021-06-14
2246111974618367K203540Bridge Occlusion BalloonMJN2020-12-23
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
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
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
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
2246111498845986K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035MCW2013-01-25
2246111975572961K120964UPSTREAM GR CATHETERDQY2012-05-25
2246111365517418K112887UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTORDYB2012-03-21
2246111195165916K1120328FR TURBO - TANDEM SYSTEMDQY2011-10-17
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
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
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
2246111742476424K022138SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028DQY2002-09-23
2246111662767128DEN210024CavaClear Laser SheathQRJ2021-12-21
2246211454468022
2246111844804412
2246111245538456

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MCW162025-03-13
DQY72015-02-27
DRE62016-07-08
MJN32025-06-24
DRB32014-08-12
PDU32007-07-11
ONU22017-07-26
QEZ22008-03-28
QRJ12021-12-21
PNO12015-04-08
DYB12012-03-21
OFC12010-03-26
DQX12008-02-26
NWX12007-01-08
MFA11997-12-09
LPC11993-02-19

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.

42 records. Showing 1-40. Next

GUDID

80 records. Showing 1-40. Next