Cleared Traditional

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

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

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

Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 13, 2019 after a review of 198 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Acist Medical Systems, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBI Catheter, Pressure Monitoring, Cardiac
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition To Measure Pressure Within The Cardiovascular System.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.