Cleared Traditional

K190473 - ACIST RXi System and Navvus II Catheter
(FDA 510(k) Clearance)

K190473 · Acist Medical Systems, Inc. · Cardiovascular device
Sep 2019
Decision
198d
Days
Class 2
Risk

K190473 is an FDA 510(k) clearance for the ACIST RXi System and Navvus II Catheter. This device is classified as a Catheter, Pressure Monitoring, Cardiac (Class II - Special Controls, product code OBI).

Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 13, 2019, 198 days after receiving the submission on February 27, 2019.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200. To Measure Pressure Within The Cardiovascular System..

Submission Details

510(k) Number K190473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2019
Decision Date September 13, 2019
Days to Decision 198 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code OBI — Catheter, Pressure Monitoring, Cardiac
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.1200
Definition To Measure Pressure Within The Cardiovascular System.