Cleared Traditional

K113584 - PRESSUREWIRE CERTUS

K113584 is the FDA 510(k) clearance for PRESSUREWIRE CERTUS by St Jude Medical. It is a Class 2 Cardiovascular device (product code DXO) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K113584 · St Jude Medical · Cardiovascular device
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Mar 2012
Decision
88d
Days
Class 2
Risk

K113584 is an FDA 510(k) clearance for the PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by St Jude Medical (Westford, US). The FDA issued a Cleared decision on March 2, 2012 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all St Jude Medical devices

Submission Details

510(k) Number K113584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date March 02, 2012
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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 25
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K113584.
Comet Pressure Guidewire
K151610 · Boston Scientific Corporation · Oct 2015
TruWave Disposable Pressure Transducer
K142749 · Edwards Lifesciences, LLC · Jan 2015
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K141495 · Edwards Lifesciences, LLC · Sep 2014
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
K070487 · Volcano Corporation · Mar 2007
WIRELESS PHYSIOLOGIC MONITORING SYSTEM
K053016 · Edwards Lifesciences, LLC · Dec 2005
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
K925638 · Baxter Healthcare Corp · Oct 1993