TRANS AORTIC MEDICAL INC

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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) (3)

Premarket Exempt

Clear

transGlide Expandable Introducer - 00866697000200 Catalog Number : TA-004

Device Description : 16F transGlide Expandable Introducer

Device Class : 2

Duns Number: 071067163

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

transGlide Expandable Introducer - 00866697000217 Catalog Number : TA-005

Device Description : 18F transGlide Expandable Introducer

Device Class : 2

Duns Number: 071067163

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

transGlide Expandable Introducer - 00866697000224 Catalog Number : TA-006

Device Description : 20F transGlide Expandable Introducer

Device Class : 2

Duns Number: 071067163

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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