Cleared Traditional

Vessel Dilator

K163524 · Fetzer Medical GmbH & Co. KG · Cardiovascular
Jun 2017
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K163524 is an FDA 510(k) clearance for the Vessel Dilator, a Dilator, Vessel, Surgical (Class II — Special Controls, product code DWP), submitted by Fetzer Medical GmbH & Co. KG (Tuttlingen, DE). The FDA issued a Cleared decision on June 29, 2017, 196 days after receiving the submission on December 15, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4475.

Submission Details

510(k) Number K163524 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2016
Decision Date June 29, 2017
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWP — Dilator, Vessel, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4475

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