Cleared Traditional

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_

K233904 · Acist Medical Systems, Inc. · Cardiovascular
Jul 2024
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K233904 is an FDA 510(k) clearance for the ACIST RXi System (016616); ACIST Navvus II Catheter (016675_, a Transducer, Pressure, Catheter Tip (Class II — Special Controls, product code DXO), submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on July 17, 2024, 219 days after receiving the submission on December 11, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number K233904 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2023
Decision Date July 17, 2024
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXO — Transducer, Pressure, Catheter Tip
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2870

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