ONSET 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

SOLOPATH - 00852381004203 Catalog Number : STFI-1425

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004210 Catalog Number : STFI-1435

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004227 Catalog Number : STFI-1625

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004234 Catalog Number : STFI-1635

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004241 Catalog Number : STFI-1825

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004258 Catalog Number : STFI-1835

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004265 Catalog Number : STFI-1925

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004272 Catalog Number : STFI-1935

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004302 Catalog Number : STFI-2125

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004319 Catalog Number : STFI-2135

Device Description : SOLOPATH Balloon Expandable TransFemoral System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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