Cleared Special

Impress Angiographic Catheter

K233268 · Merit Medical Systems, Inc. · Cardiovascular
May 2024
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K233268 is an FDA 510(k) clearance for the Impress Angiographic Catheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 22, 2024, 236 days after receiving the submission on September 29, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K233268 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date May 22, 2024
Days to Decision 236 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200

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