CARDIOGARD MEDICAL 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

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (1)

Premarket Exempt

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CardioGard Emboli Protection Cannula - 07290016069013 Catalog Number : CGT2422

Device Description : 24 Fr. (8.00 mm) Cardiopulmonary bypass cannula, arterial, for use in aorta, wit 24 Fr. (8.00 mm) Cardiopulmonary bypass cannula, arterial, for use in aorta, with suction port in tip to allow emboli removal during cardiopulmonary bypass.

Device Class :

Duns Number: 533658675

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

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