Cleared Traditional

K140466 - PRESSUREWIRE: AERIS AGILE TIP

K140466 is an FDA 510(k) clearance for PRESSUREWIRE: AERIS AGILE TIP, manufactured by St. Jude Medical Systems AB. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K140466 · St. Jude Medical Systems AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
262d
Days
Class 2
Risk

K140466 is an FDA 510(k) clearance for the PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS .... Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by St. Jude Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on November 13, 2014 after a review of 262 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 St. Jude Medical Systems AB devices

FDA 510(k) Submission Details - K140466

510(k) Number K140466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2014
Decision Date November 13, 2014
Days to Decision 262 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
137d slower than avg
Panel avg: 125d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXO Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K140466.
PressureWire X Guidewire
K161171 · St. Jude Medical, Inc. · Aug 2016
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
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
K113584 · St Jude Medical · Mar 2012
CARDIA-CATH
K112323 · Millar Instruments, Inc. · Oct 2011