Cleared Traditional

Expro Elite Snare, Sympro Elite Snare

K163307 · Vascular Solutions, Inc. · Cardiovascular
Mar 2017
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K163307 is an FDA 510(k) clearance for the Expro Elite Snare, Sympro Elite Snare, a Device, Percutaneous Retrieval (Class II — Special Controls, product code MMX), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on March 8, 2017, 105 days after receiving the submission on November 23, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K163307 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2016
Decision Date March 08, 2017
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MMX — Device, Percutaneous Retrieval
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150

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