FDA.reportPublic FDA data

Lutonix

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30065138223006513822Lutonix, Inc.1N2026-01-011625 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 GUDIDProductPhoneEmail
00801741163432LUTONIX® Drug Coated Balloon - Lutonix 035 DCB, 7mm x 80mm x 130cm, 5F+1(800)321-4254medical.services@crbard.com
00801741177323LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX100CM+1(800)321-4254medical.services@crbard.com
00801741177330LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX100CM+1(800)321-4254medical.services@crbard.com
00801741177392LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X100MMX100CM+1(800)321-4254medical.services@crbard.com
00801741177408LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX100CM+1(800)321-4254medical.services@crbard.com
00801741177415LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX100CM+1(800)321-4254medical.services@crbard.com
00801741177422LUTONIX® Drug Coated Balloon - LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX100CM+1(800)321-4254medical.services@crbard.com
00801741187704LUTONIX® Drug Coated Balloon - Lutonix 035 7X100MMX75CM+1(800)321-4254medical.services@crbard.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1405651502574195P170003LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010PRC2017-08-25
1405651458262242P130024LUTONIX DRUG COATED BALLOON PTA CATETERONU2014-10-09
1405651321830842
1405651826337148

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PRC12017-08-25
ONU12014-10-09

PMA#

50 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next