TERUMO MEDICAL 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

INTRODUCER, CATHETER (DYB) (10)

Premarket Exempt

Clear

GLIDESHEATH SLENDER - 00389701012049 Catalog Number : 80-1050

Device Description : GLIDESHEATH SLENDER Stainless Steel Kit

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

GLIDESHEATH SLENDER - 00389701012056 Catalog Number : 80-1055

Device Description : GLIDESHEATH SLENDER Stainless Steel Kit

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

GLIDESHEATH SLENDER - 00389701012063 Catalog Number : 80-1060

Device Description : GLIDESHEATH SLENDER Stainless Steel Kit

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

GLIDESHEATH SLENDER - 00389701012070 Catalog Number : 80-1065

Device Description : GLIDESHEATH SLENDER Stainless Steel Kit

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

GLIDESHEATH SLENDER - 00389701012087 Catalog Number : 80-1070

Device Description : GLIDESHEATH SLENDER Stainless Steel Kit

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

GLIDESHEATH SLENDER - 00389701012094 Catalog Number : 80-1075

Device Description : GLIDESHEATH SLENDER Stainless Steel Kit

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

GLIDESHEATH SLENDER - 00389701012100 Catalog Number : 80-1650

Device Description : GLIDESHEATH SLENDER Stainless Steel Kit

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

GLIDESHEATH SLENDER - 00389701012117 Catalog Number : 80-1660

Device Description : GLIDESHEATH SLENDER Stainless Steel Kit

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

GLIDESHEATH SLENDER - 00389701012124 Catalog Number : 80-1670

Device Description : GLIDESHEATH SLENDER Stainless Steel Kit

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

SOLOPATH - 00389701012131 Catalog Number : STFI-1425

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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