Cleared Traditional

Captus Vascular Retrieval System

K170987 · Avantec Vascular Corporation · Cardiovascular

Aug 2017

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K170987 is an FDA 510(k) clearance for the Captus Vascular Retrieval System, a Device, Percutaneous Retrieval (Class II — Special Controls, product code MMX), submitted by Avantec Vascular Corporation (Sunnyvale, US). The FDA issued a Cleared decision on August 28, 2017, 147 days after receiving the submission on April 3, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K170987 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2017
Decision Date	August 28, 2017
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF