Cleared Traditional

SavvyWire

K213854 · Opsens, Inc. · Cardiovascular
Sep 2022
Decision
278d
Days
Class 2
Risk

About This 510(k) Submission

K213854 is an FDA 510(k) clearance for the SavvyWire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Opsens, Inc. (Quebec, CA). The FDA issued a Cleared decision on September 14, 2022, 278 days after receiving the submission on December 10, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K213854 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2021
Decision Date September 14, 2022
Days to Decision 278 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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