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) (8)

Premarket Exempt

Clear

SOLOPATH - 00852381004340 Catalog Number : SR-1925

Device Description : SOLOPATH Re-collapsible Access System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004357 Catalog Number : SR-1935

Device Description : SOLOPATH Re-collapsible Access System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004388 Catalog Number : SR-2225

Device Description : SOLOPATH Re-collapsible Access System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004395 Catalog Number : SR-2235

Device Description : SOLOPATH Re-collapsible Access System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004401 Catalog Number : SR-2425

Device Description : SOLOPATH Re-collapsible Access System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381004418 Catalog Number : SR-2435

Device Description : SOLOPATH Re-collapsible Access System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381011898 Catalog Number : SR-2025

Device Description : SOLOPATH Re-collapsible Balloon Access System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SOLOPATH - 00852381011904 Catalog Number : SR-2035

Device Description : SOLOPATH Re-collapsible Balloon Access System

Device Class : 2

Duns Number: 144431850

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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