FDA.reportPublic FDA data

Lutonix 035 Drug Coated Balloon PTA Catheter

Primary DI
00801741202575
Brand
Lutonix 035 Drug Coated Balloon PTA Catheter
Company
LUTONIX, INC.
Model
LX35751260V
Catalog number
LX35751260V
Device description
Lutonix 035 12X60MMx75CM
Published
2020-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PRCDrug-coated peripheral transluminal angioplasty catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRCDrug-Coated Peripheral Transluminal Angioplasty CatheterUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741202575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741202575008017412025758017412025750801741202575

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, drug-coatedA sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
946734808
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741187704LUTONIX® Drug Coated BalloonLX35757100VLX35757100V2020-01-31
00801741163432LUTONIX® Drug Coated BalloonLX351307805FLX351307805F2018-09-14
00801741177422LUTONIX® Drug Coated BalloonLX1810062205FLX1810062205F2019-01-11
00801741187698LUTONIX® Drug Coated BalloonLX3575780VLX3575780V2020-01-31
00801741184673LUTONIX® Drug Coated BalloonLX1810043005FLX1810043005F2020-01-28
00801741184697LUTONIX® Drug Coated BalloonLX1810063005FLX1810063005F2020-01-29
00801741123320LUTONIX® Drug Coated BalloonLX351307605FLX351307605F2016-04-25
00801741135330LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX35754100VLX35754100V2017-08-28
00801741135378LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX35755100VLX35755100V2017-08-28
00801741135385LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX3575640VLX3575640V2017-08-28
00801741135392LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX3575660VLX3575660V2017-08-28
00801741135415LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX35756100VLX35756100V2017-08-28
00801741135439LUTONIX ® 035 Drug Coated Balloon PTA CatheterLX3575760VLX3575760V2017-08-28
00801741163456LUTONIX® Drug Coated BalloonLX3513071205FLX3513071205F2018-09-14
00801741163470LUTONIX® Drug Coated BalloonLX3513072205FLX3513072205F2018-09-14
00801741177279LUTONIX® Drug Coated BalloonLX1810041504FLX1810041504F2019-01-10
00801741177286LUTONIX® Drug Coated BalloonLX1810042204FLX1810042204F2019-01-11
00801741177316LUTONIX® Drug Coated BalloonLX181005805FLX181005805F2019-01-29
00801741177323LUTONIX® Drug Coated BalloonLX1810051005FLX1810051005F2019-01-29
00801741177330LUTONIX® Drug Coated BalloonLX1810051205FLX1810051205F2019-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741187636LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187643LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187681LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187698LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187704LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187759LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187766LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187803LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00763000232719IN.PACT™ AVMEDTRONIC, INC.PRC2020-01-24
00763000232979IN.PACT™ AVMEDTRONIC, INC.PRC2020-01-24
00763000233235IN.PACT™ AVMEDTRONIC, INC.PRC2020-01-24
00763000232467IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232474IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232481IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232498IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232511IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232528IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232535IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232542IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232566IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232573IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232580IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232597IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232610IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232627IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232634IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232641IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232658IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232665IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232672IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06