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 - 00801741088360 Catalog Number : LX35100680

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x80mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Lutonix® Drug Coated Balloon - 00801741088384 Catalog Number : LX351004100

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x100mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Lutonix® Drug Coated Balloon - 00801741088391 Catalog Number : LX351005100

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 5x100mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Lutonix® Drug Coated Balloon - 00801741088407 Catalog Number : LX351006100

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x100mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088421 Catalog Number : LX351004120

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 4x120mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088438 Catalog Number : LX351005120

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 5x120mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088445 Catalog Number : LX351006120

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 6x120mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088469 Catalog Number : LX351004150

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 4x150mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088476 Catalog Number : LX351005150

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 5x150mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088483 Catalog Number : LX351006150

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 6x150mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

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