Captus Vascular Retrieval System

GUDID B342CAP14120

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.

Avantec Vascular Corporation

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• Primary Device ID: B342CAP14120
• NIH Device Record Key: 1b456ec7-310b-4a12-a9bd-946e0fcf7eeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Captus Vascular Retrieval System
• Version Model Number: CAP1412
• Company DUNS: 797246308
• Company Name: Avantec Vascular Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B342CAP14120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170987

FDA Product Code

• MMX: Device, Percutaneous Retrieval

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-21
• Device Publish Date: 2021-07-13