LUTONIX, INC.

Address:1625 West 3rd Street,Tempe,AZ,85281,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Drug-Eluting Peripheral Transluminal Angioplasty Catheter (ONU) (10)

Premarket Exempt

No Yes

Clear

Lutonix® Drug Coated Balloon - 00801741088643 Catalog Number : LX35130680

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x80mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088650 Catalog Number : LX35130780

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x80mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Lutonix® Drug Coated Balloon - 00801741088667 Catalog Number : LX351304100

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x100mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Lutonix® Drug Coated Balloon - 00801741088674 Catalog Number : LX351305100

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x100mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Lutonix® Drug Coated Balloon - 00801741088681 Catalog Number : LX351306100

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x100mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088698 Catalog Number : LX351307100

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm 7x100mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088704 Catalog Number : LX351304120

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x120mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088711 Catalog Number : LX351305120

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x120mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088728 Catalog Number : LX351306120

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088735 Catalog Number : LX351307120

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x120mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

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