NOVATE MEDICAL LIMITED

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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

Filter, Intravascular, Cardiovascular (DTK) (1)

Premarket Exempt

Clear

Sentry IVC Filter - 05391529380069 Catalog Number : NM60-16-28

Device Description : The Sentry IVC Filter is indicated for the prevention of recurrent Pulmonary Emb The Sentry IVC Filter is indicated for the prevention of recurrent Pulmonary Embolism via percutaneous placement in the inferior vena cava in patients at transient risk of PE, in the following situations:• Pulmonary thromboembolism when anticoagulants are contraindicated.• Failure of anticoagulant therapy in thromboembolic diseases.• Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced.

Device Class : 2

Duns Number: 896415242

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

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