LUTONIX

FDA Filings

This page includes the latest FDA filings for LUTONIX. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
LUTONIX
LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 90102019-11-26
LUTONIX
LUTONIX 035 Drug Coated Balloon PTA Catheter2019-10-02
LUTONIX
Lutonix Drug Coated Balloon PTA Catheter2019-09-13
LUTONIX
Lutonix 035 Drug Coated Balloon PTA Catheter2019-06-24
LUTONIX
Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)2019-05-23
LUTONIX
Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)2019-05-23
LUTONIX
Lutonix 035 Drug Coated Balloon PTA Catheter2019-02-14
LUTONIX
Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)2018-12-18
LUTONIX
Lutonix 018 Drug Coated Balloon PTA Catheter2018-12-18
LUTONIX
Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)2018-09-10
LUTONIX
Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)2018-08-29
LUTONIX
Lutonix Drug Coated Ballon2018-06-28
LUTONIX
Lutonix Drug Coated Balloon2018-06-28
LUTONIX
LUTONIX® 035 Drug Coated Balloon PTA Catheter2018-06-15
LUTONIX
Lutonix Drug Coated Balloon2018-02-26
LUTONIX
Lutonix 035 Drug Coated Balloon PTA Catheter2018-02-06
LUTONIX
Lutonix Drug Coated Balloon2017-11-28
LUTONIX
LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 90102017-08-25
LUTONIX
Lutonix Drug Coated Balloon PTA Cateter2017-03-07
LUTONIX
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER2017-02-07
LUTONIX
LUTONIX DRUG COATED BALLOON2016-12-16
LUTONIX
LUTONIX 035 DRUG COATED BALLOON PTA CATETER2016-11-14
LUTONIX
LUTONIX 035 DRUG COATED BALLOON PTA CATETER2016-11-09
LUTONIX
LUTONIX DRUG COATED BALLOON PTA CATETER2016-10-14
LUTONIX
LUTONIX DRUG COATED BALLOON PTA CATHETER2016-06-28
LUTONIX
LUTONIX DRUG COATED BALLOON PTA CATHETER2016-05-05
LUTONIX
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER2016-03-10
LUTONIX
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER2016-01-29
LUTONIX
LUTONIX 035 DRUG COATED BALLOON PTA CATHETER2015-11-24
LUTONIX
LUTONIX DRUG COATED BALLOON2015-11-23

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-17
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-09-16
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-06-07
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-06-07
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-06-07
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-06-07
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-06-07
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-06-07
LUTONIX® Drug Coated Balloon
LUTONIX, INC.2019-06-07

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