Cleared Traditional

K113584 - PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER

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

K113584 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K113584

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.

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 57
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K113584.
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K141495 · Edwards Lifesciences, LLC · Sep 2014
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
K132474 · Acist Medical Systems · Jan 2014
PRESSUREWIRE
K131452 · St. Jude Medical Systems AB · Sep 2013
CARDIA-CATH
K112323 · Millar Instruments, Inc. · Oct 2011
MIKRO-CATH, MODEL 825-0101
K093111 · Millar Instruments, Inc. · Jan 2010
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
K080813 · Radi Medical Systems AB · Jul 2008