Cleared Special

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

K202543 · Volcano Corporation · Cardiovascular
Sep 2020
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K202543 is an FDA 510(k) clearance for the OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on September 28, 2020, 26 days after receiving the submission on September 2, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K202543 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2020
Decision Date September 28, 2020
Days to Decision 26 days
Submission Type Special
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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