Lutonix, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3006513822	3006513822	Lutonix, Inc.	1	N	2026-01-01	1625 West 3rd Street Tempe AZ US 85281

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00801741123320	LUTONIX® Drug Coated Balloon - "LUTONIX® 035 Drug Coated Balloon PTA Catheter .035"" 130cm 7x60mm 5 French"	+1(800)321-4254	medical.services@crbard.com
00801741135330	LUTONIX ® 035 Drug Coated Balloon PTA Catheter - Lutonix® AV Drug Coated Balloon PTA Catheter 4x100x75	+1(800)321-4254	medical.services@crbard.com
00801741163432	LUTONIX® Drug Coated Balloon - Lutonix 035 DCB, 7mm x 80mm x 130cm, 5F	+1(800)321-4254	medical.services@crbard.com

crbard.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
140565	1502574195	P170003	LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010	PRC	2017-08-25
140565	1458262242	P130024	LUTONIX DRUG COATED BALLOON PTA CATETER	ONU	2014-10-09
140565	1321830842
140565	1826337148

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PRC	1	2017-08-25
ONU	1	2014-10-09

GUDID#

LUTONIX® Drug Coated Balloon - Lutonix 035 7X100MMX75CM
LUTONIX, INC.
2020-01-31
LUTONIX® Drug Coated Balloon - Lutonix 035 DCB, 7mm x 80mm x 130cm, 5F
LUTONIX, INC.
2018-09-14
LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX100CM
LUTONIX, INC.
2019-01-11
LUTONIX® Drug Coated Balloon - Lutonix 035 7X80MMX75CM
LUTONIX, INC.
2020-01-31
LUTONIX® Drug Coated Balloon - Lutonix 018 4X300MMX100CM
LUTONIX, INC.
2020-01-28
LUTONIX® Drug Coated Balloon - Lutonix 018 6X300MMX100CM
LUTONIX, INC.
2020-01-29
LUTONIX® Drug Coated Balloon - "LUTONIX® 035 Drug Coated Balloon PTA Catheter .035"" 130cm 7x60mm 5 French"
LUTONIX, INC.
2016-04-25
LUTONIX ® 035 Drug Coated Balloon PTA Catheter - Lutonix® AV Drug Coated Balloon PTA Catheter 4x100x75
LUTONIX, INC.
2017-08-28
LUTONIX ® 035 Drug Coated Balloon PTA Catheter - Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x75
LUTONIX, INC.
2017-08-28
LUTONIX ® 035 Drug Coated Balloon PTA Catheter - Lutonix® AV Drug Coated Balloon PTA Catheter 6x40x75
LUTONIX, INC.
2017-08-28
LUTONIX ® 035 Drug Coated Balloon PTA Catheter - Lutonix® AV Drug Coated Balloon PTA Catheter 6x60x75
LUTONIX, INC.
2017-08-28
LUTONIX ® 035 Drug Coated Balloon PTA Catheter - Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x75
LUTONIX, INC.
2017-08-28
LUTONIX ® 035 Drug Coated Balloon PTA Catheter - Lutonix® AV Drug Coated Balloon PTA Catheter 7x60x75
LUTONIX, INC.
2017-08-28
LUTONIX® Drug Coated Balloon - Lutonix 035 DCB, 7mm x 120mm x 130cm, 5F
LUTONIX, INC.
2018-09-14
LUTONIX® Drug Coated Balloon - Lutonix 035 DCB, 7mm x 220mm x 130cm, 5F
LUTONIX, INC.
2018-09-14
LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X150MMX100CM
LUTONIX, INC.
2019-01-10
LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X220MMX100CM
LUTONIX, INC.
2019-01-11
LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X80MMX100CM
LUTONIX, INC.
2019-01-29
LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX100CM
LUTONIX, INC.
2019-01-29
LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX100CM
LUTONIX, INC.
2019-01-29
LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X100MMX100CM
LUTONIX, INC.
2019-01-29
LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX100CM
LUTONIX, INC.
2019-01-29
LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX100CM
LUTONIX, INC.
2019-01-11
LUTONIX® Drug Coated Balloon - Lutonix 018 6X300MMX130CM
LUTONIX, INC.
2020-01-30
LUTONIX® Drug Coated Balloon - Lutonix 018 5X300MMX100CM
LUTONIX, INC.
2020-01-29
LUTONIX® Drug Coated Balloon - Lutonix 018 4X300MMX130CM
LUTONIX, INC.
2020-01-29
LUTONIX® Drug Coated Balloon - Lutonix 018 5X300MMX130CM
LUTONIX, INC.
2020-01-29
LUTONIX ® Drug Coated Balloon - Lutonix 018 7X80MMX100CM
LUTONIX, INC.
2019-05-30
LUTONIX® Drug Coated Balloon - Lutonix 018 7X100MMX100CM
LUTONIX, INC.
2019-05-30
LUTONIX® Drug Coated Balloon - Lutonix 018 7X120MMX100CM
LUTONIX, INC.
2019-05-30
LUTONIX® Drug Coated Balloon - Lutonix 018 7X150MMX100CM
LUTONIX, INC.
2019-05-30
LUTONIX® Drug Coated Balloon - Lutonix 018 7X220MMX100CM
LUTONIX, INC.
2019-05-30
LUTONIX® Drug Coated Balloon - Lutonix 018 7X80MMX130CM
LUTONIX, INC.
2019-05-30
LUTONIX® Drug Coated Balloon - Lutonix 018 7X100MMX130CM
LUTONIX, INC.
2019-05-30
LUTONIX® Drug Coated Balloon - Lutonix 018 7X120MMX130CM
LUTONIX, INC.
2019-05-30
LUTONIX® Drug Coated Balloon - Lutonix 018 7X150MMX130CM
LUTONIX, INC.
2019-05-30
LUTONIX® Drug Coated Balloon - Lutonix 018 7X220MMX130CM
LUTONIX, INC.
2019-05-30
LUTONIX® Drug Coated Balloon - "LUTONIX® 035 Drug Coated Balloon PTA Catheter .035"" 130cm 4x40mm 5 French"
LUTONIX, INC.
2016-04-25
LUTONIX® Drug Coated Balloon - "LUTONIX® 035 Drug Coated Balloon PTA Catheter .035"" 130cm 4x60mm 5 French"
LUTONIX, INC.
2016-04-25
LUTONIX® Drug Coated Balloon - "LUTONIX® 035 Drug Coated Balloon PTA Catheter .035"" 130cm 4x80mm 5 French"
LUTONIX, INC.
2016-04-25

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