TERUMO CORPORATION

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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

CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (10)

Premarket Exempt

No Yes

Clear

OPTITORQUE - 04987350700209 Catalog Number : RH*5JR3500A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700223 Catalog Number : RH*5JR4000A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700247 Catalog Number : RH*5JR5000A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class :

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700261 Catalog Number : RH*5BPIR00A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700285 Catalog Number : RH*5SAL100A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700308 Catalog Number : RH*5SAL200A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700322 Catalog Number : RH*6TIG110A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700346 Catalog Number : RH*6TIG210A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class :

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700360 Catalog Number : RH*6BL3520A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

OPTITORQUE - 04987350700384 Catalog Number : RH*6BL4020A

Device Description : RADIFOCUS OPTITORQUE Angiographic Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

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