Cleared Traditional

Pre-Formed Blue

K221575 · Lake Region Medical · Cardiovascular
Oct 2022
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K221575 is an FDA 510(k) clearance for the Pre-Formed Blue, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Lake Region Medical (Chaska, US). The FDA issued a Cleared decision on October 7, 2022, 128 days after receiving the submission on June 1, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K221575 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2022
Decision Date October 07, 2022
Days to Decision 128 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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