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Spectranetics Corp.

157 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
ELCA Coronary Atherectomy Catheters (P910001/S125)Spectranetics Corp.2025-12-18
AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S035)Spectranetics Corp.2025-04-04
AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S036)Spectranetics Corp.2025-01-15
Philips Laser System (P910001/S123)Spectranetics Corp.2024-11-21
ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS) (P910001/S122)Spectranetics Corp.2024-09-05
AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S034)Spectranetics Corp.2024-02-14
Philips Laser System (P910001/S121)Spectranetics Corp.2023-10-30
AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S033)Spectranetics Corp.2023-10-19
Philips Laser System (P910001/S120)Spectranetics Corp.2023-08-31
AngioSculpt RX PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S032)Spectranetics Corp.2023-07-07
ECLA Coronary Atherectomy Catheters (P910001/S119)Spectranetics Corp.2023-05-04
ELCA Coronary Atherectomy Catheters (P910001/S118)Spectranetics Corp.2023-03-21
ELCA Coronary Laser Catheters (P910001/S117)Spectranetics Corp.2022-10-21
ELCA Coronoary Laser Atherectomy Catheter (P910001/S116)Spectranetics Corp.2022-08-19
Philips Laser System (P910001/S115)Spectranetics Corp.2022-05-05
ELCA Coronary Atherectomy Catheters (P910001/S114)Spectranetics Corp.2022-02-24
AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter) (P050018/S030)Spectranetics Corp.2021-12-23
Spectranetics Laser Sheath (SLS) (P910001/S112)Spectranetics Corp.2021-09-02
AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S031)Spectranetics Corp.2021-07-27
ELCA Coronary Atherectomy Catheter (P910001/S113)Spectranetics Corp.2021-05-11
Spectranetics CVX-300 Excimer Laser System (P910001/S111)Spectranetics Corp.2020-12-22
AngioSculpt PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S028)Spectranetics Corp.2020-09-21
AngioSculpt PTCA Scoring Balloon Catheter, Rapid Exchange (RX) (P050018/S026)Spectranetics Corp.2020-09-11
CVX-3000 Excimer Lasert System and ELCA Coronary Atherectomy Catheters (P910001/S110)Spectranetics Corp.2019-10-21
AngioSculpt PTCA Scoring Balloon Catheter (P050018/S027)Spectranetics Corp.2019-08-22
CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters (P910001/S109)Spectranetics Corp.2019-03-20
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S108)Spectranetics Corp.2018-11-16
AngioSculpt PTCA Scoring Balloon Catheter (P050018/S025)Spectranetics Corp.2018-10-15
CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters (P910001/S107)Spectranetics Corp.2018-10-15
CVX-300 and CVX-300-P Excimer Laser Systems (P910001/S106)Spectranetics Corp.2018-09-25
ELCA Coronary Atherectomy Catheters (P910001/S105)Spectranetics Corp.2018-08-14
CVX-300 and CVX-300-P EXCIMER LASER SYSTEM (P910001/S089)Spectranetics Corp.2018-07-27
CVX-300-P Excimer Laser System (P910001/S097)Spectranetics Corp.2018-06-29
CVX-300 Excimer Laser System/ELCA Coronary Atherectomy Catheter (P910001/S104)Spectranetics Corp.2018-05-08
ELCA Laser Catheters (P910001/S103)Spectranetics Corp.2018-03-29
CVX-300 Excimer Laser System (P910001/S102)Spectranetics Corp.2017-12-22
ELCA Coronary Laser Atherectomy Catheters (P910001/S099)Spectranetics Corp.2017-09-21
ELCA Coronary Laser Atherectomy Catheters (P910001/S098)Spectranetics Corp.2017-09-01
ELCA Laser Catheters (P910001/S096)Spectranetics Corp.2017-08-25
ELCA Catheters (P910001/S095)Spectranetics Corp.2017-08-22
ELCA (P910001/S094)Spectranetics Corp.2017-07-18
Spectranetics CVX-300 Exclimer Laser System (P910001/S091)Spectranetics Corp.2017-07-07
CVX-300 and CVX-300P Excimer Laser Systems (P910001/S093)Spectranetics Corp.2017-06-20
ECLA GlideLight Catheter (P910001/S092)Spectranetics Corp.2017-04-24
AngioSculpt RX PTCA Scoring Balloon Catheter (P050018/S024)Spectranetics Corp.2017-04-17
ELCA (P910001/S090)Spectranetics Corp.2017-01-05
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S088)Spectranetics Corp.2016-10-13
ANGIOSCULPT(R) PTCA SCORING BALLOON CATHETER (P050018/S022)Spectranetics Corp.2016-09-06
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S079)Spectranetics Corp.2016-08-31
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S087)Spectranetics Corp.2016-07-07
EXCIMER LASER CORONARY ATHERECTOMY CATHETER (P910001/S086)Spectranetics Corp.2016-06-16
ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S021)Spectranetics Corp.2016-04-26
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S085)Spectranetics Corp.2016-04-13
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S084)Spectranetics Corp.2016-04-07
SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM (P910001/S083)Spectranetics Corp.2016-02-12
ELCA CORONARY LASER ATHERCOTOMY CATHETER (ELCA 2.0 VITESSE ELL) (P910001/S082)Spectranetics Corp.2015-12-18
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S081)Spectranetics Corp.2015-12-03
CVX-300/CVX300-P EXCIMER LASER SYSTEM (P910001/S078)Spectranetics Corp.2015-10-20
ELCA CORONARY LASER ATHERECTOMY CATHETERS (P910001/S080)Spectranetics Corp.2015-09-30
SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM (P910001/S077)Spectranetics Corp.2015-02-05
SPECTRANETICS EXCIMER CORONARY LASER ATHERECTOMY (ELCA) CATHETERS (P910001/S076)Spectranetics Corp.2015-01-08
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S075)Spectranetics Corp.2015-01-07
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S074)Spectranetics Corp.2014-12-16
EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER (P910001/S072)Spectranetics Corp.2014-10-09
CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS (P910001/S073)Spectranetics Corp.2014-08-21
CVX-300 & CVX-300P EXCIMER LASER SYSTEM (P910001/S071)Spectranetics Corp.2014-06-30
ELCA CORONARY ATHRECTOMY CATHETERS (P910001/S070)Spectranetics Corp.2014-04-17
CVX-300 EXCIMER LASER SYSTEM (P910001/S065)Spectranetics Corp.2014-01-14
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S069)Spectranetics Corp.2014-01-14
CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS (P910001/S067)Spectranetics Corp.2013-10-02
CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS (P910001/S066)Spectranetics Corp.2013-08-21
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S019)Spectranetics Corp.2013-08-21
ANGIOSCULPT PTCA SCORING BALLOON CATHETER - RAPID EXCHANGE (RX), ANGIOSCULPT PTCS SCORING BALLOON CATHETER - EASY EXCHAN (P050018/S018)Spectranetics Corp.2013-05-20
EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER (P910001/S059)Spectranetics Corp.2013-04-04
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S064)Spectranetics Corp.2013-02-28
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S017)Spectranetics Corp.2013-01-10
CVX-300 EXCIMER LASER SYSTEM (P910001/S063)Spectranetics Corp.2013-01-08
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S062)Spectranetics Corp.2012-12-26
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S061)Spectranetics Corp.2012-09-05
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S060)Spectranetics Corp.2012-07-31
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S058)Spectranetics Corp.2012-07-25
CVX-300 ANTI-REFLECTIVE WINDOW (P910001/S057)Spectranetics Corp.2012-07-06
SPECTRANETICS EXCIMER LASER (P910001/S056)Spectranetics Corp.2012-07-03
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S055)Spectranetics Corp.2012-05-30
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S054)Spectranetics Corp.2012-05-02
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S053)Spectranetics Corp.2012-02-24
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S051)Spectranetics Corp.2012-02-17
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S047)Spectranetics Corp.2012-01-13
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S052)Spectranetics Corp.2011-12-27
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S016)Spectranetics Corp.2011-12-20
SPECTRANETICS EXCIMER LASER (P910001/S050)Spectranetics Corp.2011-12-06
SPECTRANETICS CORONARY ATHERECTOMY (ELCA) CATHETERS (P910001/S040)Spectranetics Corp.2011-11-18
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S015)Spectranetics Corp.2011-10-27
CVX EXCIMER LASER SYSTEMS (P910001/S049)Spectranetics Corp.2011-10-25
SPECTRANETICS LASER CATHETERS ELCA (P910001/S045)Spectranetics Corp.2011-07-14
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S048)Spectranetics Corp.2011-06-08
ANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0 (P050018/S014)Spectranetics Corp.2011-05-12
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S042)Spectranetics Corp.2011-04-20
ANGIOSCULPT PTCA SCORING BALLOON CATHETER, EASY EXCHANGE (EX0 (P050018/S013)Spectranetics Corp.2011-04-08
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S012)Spectranetics Corp.2011-03-30
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Every clearance here is in the API, with alerts when new ones post.