Cleared Special

EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER (K110103) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K110103 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
29d
Days
Class 2
Risk

K110103 is an FDA 510(k) clearance for the EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Draper, US). The FDA issued a Cleared decision on February 11, 2011 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Edwards Lifesciences, LLC devices

Submission Details

510(k) Number K110103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2011
Decision Date February 11, 2011
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 155
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K110103.
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
K120495 · Boston Scientific Corp · May 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893 · Boston Scientific Corp · Mar 2012
MERIT MARQUIS FLOW SWITCH
K110643 · Merit Medical Systems, Inc. · Jul 2011
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING
K093004 · Merit Medical Systems, Inc. · Feb 2010
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K090276 · Siemens Medical Solutions USA, Inc. · Feb 2009
RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
K090040 · Terumo Medical Corp. · Feb 2009