TRANSSEPTAL SOLUTIONS LTD

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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) (1)

Premarket Exempt

Clear

TSP Crosser Transseptal Access System - 07290017811017 Catalog Number :

Device Description : The TSP Crosser System is intended to be used both to puncture the interatrial s The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers.

Device Class :

Duns Number: 532245789

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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