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-coated peripheral transluminal angioplasty catheter (PRC) (2) Drug-Eluting Peripheral Transluminal Angioplasty Catheter (ONU) (1)

Premarket Exempt

No Yes

Clear

LUTONIX® Drug Coated Balloon - 00801741199462 Catalog Number : LX1815072205F

Device Description : Lutonix 018 7X220MMX150CM

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : ONU, PRC

Prescription Use : Yes

Device Count : 1

Lutonix 035 Drug Coated Balloon PTA Catheter - 00801741202575 Catalog Number : LX35751260V

Device Description : Lutonix 035 12X60MMx75CM

Device Class : 3

Duns Number: 946734808

Premarket Exempt : No

Product Code : PRC

Prescription Use : Yes

Device Count : 1

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