Avantec Vascular Corporation

Address:870 Hermosa Avenue,SUNNYVALE,CA,94085,US

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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

Device, Percutaneous Retrieval (MMX) (1)

Premarket Exempt

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Captus Vascular Retrieval System - B342CAP14120 Catalog Number :

Device Description : The Captus Vascular Retrieval System consists of a flexible polyetheretherketone The Captus Vascular Retrieval System consists of a flexible polyetheretherketone (PEEK) and Pebax shaft with a nitinol Braided Loop Snare (BLS) on the distal end. The device is designed to capture and retrieve foreign objects from the cardiovascular system. The lumen of the 120 cm long flexible snare shaft contains an inner rod that is secured to the BLS using an ultra-high molecular weight polyethylene (UHMWPE) braided suture. The external torquer is attached to the proximal end of the shaft and supports BLS manipulation. During the procedure, once the distal end has been positioned near the foreign object, the torquer can be turned clockwise (in relation to the shaft) in order to cinch the BLS. This feature allows the foreign object to be more firmly secured before its retrieval.

Device Class : 2

Duns Number: 797246308

Premarket Exempt : No

Product Code : MMX

Prescription Use : Yes

Device Count : 1

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