Cleared Abbreviated

K082191 - CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 (FDA 510(k) Clearance)

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

K082191 · Cardiomems, Inc. · Cardiovascular device
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Aug 2008
Decision
15d
Days
Class 2
Risk

K082191 is an FDA 510(k) clearance for the CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080. Classified as Sensor, Pressure, Aneurysm, Implantable (product code NQH), Class II - Special Controls.

Submitted by Cardiomems, Inc. (Atlanta, US). The FDA issued a Cleared decision on August 19, 2008 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2855 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cardiomems, Inc. devices

Submission Details

510(k) Number K082191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2008
Decision Date August 19, 2008
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NQH Sensor, Pressure, Aneurysm, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2855
Definition This Device Is Intended To Measure The Pressure In The Aneurysm Sac During And After An Endovascular Procedure.
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.