FDA.reportPublic FDA data

Lutonix® Drug Coated Balloon

Primary DI
00801741088315
Brand
Lutonix® Drug Coated Balloon
Company
LUTONIX, INC.
Model
LX35100560
Catalog number
LX35100560
Device description
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 5x60mm
Published
2014-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONUDrug-Eluting Peripheral Transluminal Angioplasty CatheterUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741088315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741088315008017410883158017410883150801741088315

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741202575Lutonix 035 Drug Coated Balloon PTA CatheterLX35751260VLX35751260V2020-02-03
00801741187636LUTONIX® Drug Coated BalloonLX3540780VLX3540780V2020-01-31
00801741187643LUTONIX® Drug Coated BalloonLX35407100VLX35407100V2020-01-31
00801741187681LUTONIX® Drug Coated BalloonLX35401260VLX35401260V2020-01-31
00801741187698LUTONIX® Drug Coated BalloonLX3575780VLX3575780V2020-01-31
00801741187704LUTONIX® Drug Coated BalloonLX35757100VLX35757100V2020-01-31
00801741187759LUTONIX® Drug Coated BalloonLX35100780VLX35100780V2020-01-31
00801741187766LUTONIX® Drug Coated BalloonLX351007100VLX351007100V2020-01-31
00801741187803LUTONIX® Drug Coated BalloonLX351001260VLX351001260V2020-01-31
00801741184727LUTONIX® Drug Coated BalloonLX1813063005FLX1813063005F2020-01-30
00801741184680LUTONIX® Drug Coated BalloonLX1810053005FLX1810053005F2020-01-29
00801741184697LUTONIX® Drug Coated BalloonLX1810063005FLX1810063005F2020-01-29
00801741184703LUTONIX® Drug Coated BalloonLX1813043005FLX1813043005F2020-01-29
00801741184710LUTONIX® Drug Coated BalloonLX1813053005FLX1813053005F2020-01-29
00801741184673LUTONIX® Drug Coated BalloonLX1810043005FLX1810043005F2020-01-28
00801741177217LUTONIX® Drug Coated BalloonLX187572205FLX187572205F2019-10-09
00801741177170LUTONIX® Drug Coated BalloonLX18757805FLX18757805F2019-10-08
00801741177187LUTONIX® Drug Coated BalloonLX187571005FLX187571005F2019-10-08
00801741177194LUTONIX® Drug Coated BalloonLX187571205FLX187571205F2019-10-08
00801741177200LUTONIX® Drug Coated BalloonLX187571505FLX187571505F2019-10-08

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Primary DI, Brand, Company table
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