Cleared Traditional

K103094 - VIGILEO ARTERIAL PRESSURE CARDIAC OUTPU...

Also marketed or referenced as:
VIGILEO APCO / OXIMETRY MONITOR

K103094 is an FDA 510(k) clearance for VIGILEO ARTERIAL PRESSURE CARDIAC OUTPU..., manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K103094 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
210d
Days
Class 2
Risk

K103094 is an FDA 510(k) clearance for the VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on May 17, 2011 after a review of 210 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K103094

510(k) Number K103094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2010
Decision Date May 17, 2011
Days to Decision 210 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
85d slower than avg
Panel avg: 125d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 85
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