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Spectranetics Corp.

157 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S044)Spectranetics Corp.2011-02-28
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S043)Spectranetics Corp.2011-02-03
CVS-300 EXCIMER LASER SYSTEM (P910001/S034)Spectranetics Corp.2011-01-10
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S011)Spectranetics Corp.2010-12-29
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S041)Spectranetics Corp.2010-12-29
SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM (P910001/S038)Spectranetics Corp.2010-11-10
SPECTRANETICS ELCA LASER CATHETERS (P910001/S037)Spectranetics Corp.2010-10-15
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S010)Spectranetics Corp.2010-09-08
CVX-300 LASER SYSTEM (P910001/S033)Spectranetics Corp.2010-07-08
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S006)Spectranetics Corp.2009-10-30
ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S008)Spectranetics Corp.2009-10-08
CVX-3000 EXCIMER LASER CORONARY ATHRECTOMY (ELCA) SYSTEM (P910001/S032)Spectranetics Corp.2009-07-29
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S007)Spectranetics Corp.2009-06-19
CVX-300 CORONARY LASER CATHETER (P910001/S031)Spectranetics Corp.2009-06-01
SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM (P910001/S027)Spectranetics Corp.2009-03-25
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S005)Spectranetics Corp.2009-01-27
ANGIOPLASTY/LASER/CORONARY DEVICE (P910001/S028)Spectranetics Corp.2008-12-11
ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S004)Spectranetics Corp.2008-04-23
ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S003)Spectranetics Corp.2007-10-18
ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S002)Spectranetics Corp.2007-07-12
SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM (P910001/S026)Spectranetics Corp.2007-05-11
ANGIOSCUPLT SCORING BALLOON CATHETER (P050018/S001)Spectranetics Corp.2007-03-07
ANGIOSCULPT SCORING BALLOON CATHETER (P050018)Spectranetics Corp.2007-01-08
CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12 (P910001/S025)Spectranetics Corp.2006-08-02
SPECTRANECTICS VITESSE COS RX CATHETERS, VITESSE E CATHETERS AND EXTREME OTW CATHETERS (P910001/S024)Spectranetics Corp.2003-08-08
CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM (P910001/S023)Spectranetics Corp.2003-05-02
0.7 MM EXTREME CATHETER (P910001/S021)Spectranetics Corp.2003-02-04
CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM (P910001/S020)Spectranetics Corp.2001-10-10
VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002 (P910001/S019)Spectranetics Corp.2001-06-19
VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER (P910001/S018)Spectranetics Corp.2000-08-04
EXTREME XTO .9 MM CORONARY ANGIOPLASTY CATHETER (P910001/S015)Spectranetics Corp.2000-07-11
ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT (P910001/S017)Spectranetics Corp.2000-03-17
VITESSE-C OS CATHETER MODELS 114-009, 117-016, AND 120-009 (P910001/S014)Spectranetics Corp.2000-01-28
CVX-300 EXCIMER LASER SYSTEM (P910001/S016)Spectranetics Corp.1999-12-10
VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008 (P910001/S013)Spectranetics Corp.1999-03-12
VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008 (P910001/S012)Spectranetics Corp.1997-09-24
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S005)Spectranetics Corp.1995-07-31
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S008)Spectranetics Corp.1995-07-12
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S010)Spectranetics Corp.1995-05-16
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S009)Spectranetics Corp.1995-03-24
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S007)Spectranetics Corp.1994-11-15
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S006)Spectranetics Corp.1994-10-31
EXCIMER LASER (P900032/S019)Spectranetics Corp.1994-06-14
EXCIMER LASER (P900032/S018)Spectranetics Corp.1994-06-14
EXCIMER LASER (P900032/S020)Spectranetics Corp.1993-11-23
EXCIMER LASER MODEL DYMER (R) 200+ (P900032/S015)Spectranetics Corp.1993-10-25
EXCIMER LASER (LASER CATHETER-MODEL PC4030(2.0MM)) (P900032/S003)Spectranetics Corp.1993-10-19
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S001)Spectranetics Corp.1993-10-18
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S002)Spectranetics Corp.1993-09-23
EXCIMER LASER MODEL PC4016(1.3MM),4026(1.6MM) (P900032/S006)Spectranetics Corp.1993-08-12
EXCIMER LASER (LASER CATHETER-MODEL PC4010(1.3MM)) (P900032/S001)Spectranetics Corp.1993-06-22
EXCIMER LASER (LASER CATHETER-MODEL PC4021(1.6MM)) (P900032/S002)Spectranetics Corp.1993-06-22
EXCIMER LASER MODEL DYMER (R) 200+ (P900032/S016)Spectranetics Corp.1993-03-18
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001)Spectranetics Corp.1993-02-19
EXCIMER LASER MODEL LAISER II (P900032/S013)Spectranetics Corp.1993-01-08
AIS EXIMER LASER ANGIOPLASTY (P900032)Spectranetics Corp.1992-01-31
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