LUTONIX, INC.

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

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Filters

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 - 00801741088087 Catalog Number : LX3575680

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Lutonix® Drug Coated Balloon - 00801741088100 Catalog Number : LX35754100

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 75cm 4x100mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Lutonix® Drug Coated Balloon - 00801741088117 Catalog Number : LX35755100

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 75cm 5x100mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Lutonix® Drug Coated Balloon - 00801741088124 Catalog Number : LX35756100

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 75cm 6x100mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088148 Catalog Number : LX35754120

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x120mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088155 Catalog Number : LX35755120

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x120mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088162 Catalog Number : LX35756120

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088186 Catalog Number : LX35754150

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x150mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088193 Catalog Number : LX35755150

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x150mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

LUTONIX® Drug Coated Balloon - 00801741088209 Catalog Number : LX35756150

Device Description : LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x150mm

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

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