Cleared Traditional

K132474 - CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER (FDA 510(k) Clearance)

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

K132474 · Acist Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
176d
Days
Class 2
Risk

K132474 is an FDA 510(k) clearance for the CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Acist Medical Systems (Eden Prairie, US). The FDA issued a Cleared decision on January 30, 2014 after a review of 176 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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 devices

Submission Details

510(k) Number K132474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2013
Decision Date January 30, 2014
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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.

Regulatory Peers - DXO Transducer, Pressure, Catheter Tip

All 63
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K132474.
OptoMonitor 3
K251367 · Opsens, Inc. · Jan 2026
OptoMonitor 3
K241418 · Opsens, Inc. · Feb 2025
ACIST RXi System (016616)
K233904 · Acist Medical Systems, Inc. · Jul 2024
TruWave Disposable Pressure Transducer
K222216 · Edwards Lifesciences, LLC · Dec 2022
OptoMonitor 3
K202943 · Opsens, Inc. · Nov 2020
OptoMonitor 3
K193620 · Opsens, Inc. · Jun 2020