Lutonix Inc

FDA Filings

This page includes the latest FDA filings for Lutonix Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006513822
FEI Number3006513822
NameLutonix, Inc.
Owner & OperatorC. R. Bard, Inc.
Contact Address1 Becton Drive
Franklin Lakes NJ 07417 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9409 Science Center Dr
New Hope, MN 55428 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
LUTONIX, INC.
Lutonix 035 Drug Coated Balloon PTA Catheter LX35751260V2020-02-11
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX351001260V2020-02-10
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX351007100V2020-02-10
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX35100780V2020-02-10
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX35757100V2020-02-10
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX3575780V2020-02-10
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX35401260V2020-02-10
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX35407100V2020-02-10
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX3540780V2020-02-10
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1813063005F2020-02-07
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1813053005F2020-02-06
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1813043005F2020-02-06
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1810063005F2020-02-06
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1810053005F2020-02-06
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1810043005F2020-02-05
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187572205F2019-10-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187571505F2019-10-16
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187571205F2019-10-16
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187571005F2019-10-16
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18757805F2019-10-16
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18757605F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18757405F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187562205F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187561505F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187561205F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187561005F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18756805F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18756605F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18756405F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187552205F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187551505F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187551205F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187551005F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18755805F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18755605F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18755405F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187542204F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187541504F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187541204F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX187541004F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18754804F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18754604F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX18754404F2019-10-14
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815072205F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815071505F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815071205F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815071005F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181507805F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181507605F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181507405F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815062205F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815061505F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815061205F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815061005F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181506805F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181506605F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181506405F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815052205F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815051505F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815051205F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815051005F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181505805F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181505605F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181505405F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815042204F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815041504F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815041204F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1815041004F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181504804F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181504604F2019-09-17
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181504404F2019-09-16
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1813072205F2019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1813071505F2019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1813071205F2019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1813071005F2019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX181307805F2019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1810072205F2019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1810071505F2019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1810071205F2019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX1810071005F2019-09-04
LUTONIX, INC.
LUTONIX ® Drug Coated Balloon LX181007805F2019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX357551502019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX357541502019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX357561202019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX357551202019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX357541202019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX357561002019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX357551002019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX357541002019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX35756802019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX35755802019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX35754802019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX35757602019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX35756602019-09-04
LUTONIX, INC.
Lutonix ®Drug Coated Balloon LX35755602019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX35754602019-09-04
LUTONIX, INC.
LUTONIX® Drug Coated Balloon LX35757402019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX35756402019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX35755402019-09-04
LUTONIX, INC.
Lutonix® Drug Coated Balloon LX35754402019-09-04
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix Drug Coated Balloon2017-08-27
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix 035 Drug Coated Balloon PTA Catheter2017-08-27
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix 018 Drug Coated Balloon PTA Catheter2017-08-27
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix Drug Coated Balloon2014-11-12
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix 014 PTCA Drug Coated Balloon Catheter2014-11-12
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix Drug Coated Balloon2014-10-31
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix 035 Drug Coated Balloon PTA Catheter2014-10-31
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix 018 Drug Coated Balloon PTA Catheter2014-10-31
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix 014 Drug Coated Balloon PTA Catheter2014-10-31
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix Drug Coated Balloon2014-10-16
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix 035 Drug Coated Balloon PTA Catheter2014-10-16
Lutonix, Inc. [C. R. Bard, Inc.]
Lutonix 018 Drug Coated Balloon PTA Catheter2014-10-16

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