Atlas FDA

Lutonix

67 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Lutonix 018 (Model 9014) (P170003/S028)Lutonix2025-09-04
Lutonix 035 (Model 9004 and Model 9010) (P130024/S044)Lutonix2025-09-04
Lutonix Drug Coated Balloon PTA Catheter (P170003/S026)Lutonix2024-08-29
Lutonix Drug Coated Balloon PTA Catheter (P170003/S027)Lutonix2023-09-07
Lutonix Drug Coated Balloon PTA Catheter (P130024/S043)Lutonix2023-09-07
Lutonix Drug Coated Balloon PTA Catheter (P170003/S024)Lutonix2021-12-16
Lutonix 035 (P130024/S042)Lutonix2021-12-02
Lutonix 018 (P170003/S025)Lutonix2021-12-02
Lutonix 035 Drug Coated Balloon PTA Catheter (P170003/S022)Lutonix2021-09-07
Lutonix 018 Drug Coated Balloon PTA Catheters (P170003/S019)Lutonix2021-08-06
Lutonix 035 Drug Coated Balloon PTA Catheters (P130024/S038)Lutonix2021-08-06
Lutonix 035 Drug Coated Balloon Catheter, Lutonix 018 Drug Coated Balloon Catheter (P130024/S041)Lutonix2021-08-05
Lutonix 018 Drug Coated Balloon Catheter (P170003/S023)Lutonix2021-08-05
Lutonix 018 and 035 Drug Coated Balloon PTA Catheter (P170003/S021)Lutonix2021-06-03
Lutonix 018 and 035 Drug Coated Balloon (P130024/S040)Lutonix2021-06-03
Lutonix 018 Drug Coated Balloon PTA Catheter (P130024/S037)Lutonix2020-12-22
Lutonix 035 DCB PTA Catheter Balloon (P130024/S035)Lutonix2020-06-26
Lutonix 035 Drug Coated Balloon PTA Catheter (P170003/S017)Lutonix2020-05-14
Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S034)Lutonix2020-05-14
Lutonix 018 Drug Coated Balloon PTA Catheter (P170003/S018)Lutonix2020-05-04
Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S036)Lutonix2020-05-04
Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB) (P170003/S016)Lutonix2020-04-21
LUTONIX 035 Drug Coated Balloon PTA Catheter (P130024/S031)Lutonix2020-03-20
Lutonix 018 Drug Coated Balloon PTA Catheter (P130024/S033)Lutonix2020-03-02
Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB) (P130024/S030)Lutonix2019-12-19
Lutonix 018 Drug Coated Balloon PTA Catheters (P130024/S032)Lutonix2019-12-18
LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S015)Lutonix2019-12-18
LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S011)Lutonix2019-12-09
LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010 (P170003/S014)Lutonix2019-11-26
LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S007)Lutonix2019-10-04
LUTONIX 035 Drug Coated Balloon PTA Catheter (P170003/S012)Lutonix2019-10-02
Lutonix Drug Coated Balloon PTA Catheter (P130024/S029)Lutonix2019-09-13
Lutonix 035 Drug Coated Balloon PTA Catheter (P170003/S008)Lutonix2019-06-24
Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P170003/S006)Lutonix2019-05-23
Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S027)Lutonix2019-05-23
Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S026)Lutonix2019-02-14
Lutonix 018 Drug Coated Balloon PTA Catheter (P170003/S004)Lutonix2018-12-18
Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S025)Lutonix2018-12-18
Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S024)Lutonix2018-09-10
Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S022)Lutonix2018-08-29
Lutonix Drug Coated Ballon (P130024/S023)Lutonix2018-06-28
Lutonix Drug Coated Balloon (P170003/S003)Lutonix2018-06-28
LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S002)Lutonix2018-06-15
Lutonix Drug Coated Balloon (P170003/S001)Lutonix2018-02-26
Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S021)Lutonix2018-02-06
Lutonix Drug Coated Balloon (P130024/S020)Lutonix2017-11-28
LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 (P170003)Lutonix2017-08-25
Lutonix Drug Coated Balloon PTA Cateter (P130024/S018)Lutonix2017-03-07
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S009)Lutonix2017-02-07
LUTONIX DRUG COATED BALLOON (P130024/S017)Lutonix2016-12-16
LUTONIX 035 DRUG COATED BALLOON PTA CATETER (P130024/S014)Lutonix2016-11-14
LUTONIX 035 DRUG COATED BALLOON PTA CATETER (P130024/S013)Lutonix2016-11-09
LUTONIX DRUG COATED BALLOON PTA CATETER (P130024/S015)Lutonix2016-10-14
LUTONIX DRUG COATED BALLOON PTA CATHETER (P130024/S011)Lutonix2016-06-28
LUTONIX DRUG COATED BALLOON PTA CATHETER (P130024/S012)Lutonix2016-05-05
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S010)Lutonix2016-03-10
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S006)Lutonix2016-01-29
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S008)Lutonix2015-11-24
LUTONIX DRUG COATED BALLOON (P130024/S003)Lutonix2015-11-23
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S005)Lutonix2015-11-20
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S007)Lutonix2015-09-04
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S002)Lutonix2015-06-30
LUTONIX DRUG COATED BALLOON (DCB) (P130024/S004)Lutonix2015-04-23
LUTONIX DRUG COATED BALLOON (DCB) (P130024/S001)Lutonix2015-01-22
LUTONIX DRUG COATED BALLOON PTA CATETER (P130024)Lutonix2014-10-09

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Every clearance here is in the API, with alerts when new ones post.