Cleared Traditional

K083623 - CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX A...

K083623 is an FDA 510(k) clearance for CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX A..., manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K083623 · Edwards Lifesciences, LLC · Cardiovascular device
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Apr 2009
Decision
128d
Days
Class 2
Risk

K083623 is an FDA 510(k) clearance for the CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on April 15, 2009 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3800 - 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 - K083623

510(k) Number K083623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2008
Decision Date April 15, 2009
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRH Device Classification - Class 2, Special Controls

Product Code KRH Ring, Annuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3800
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 - KRH Ring, Annuloplasty

All 42
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K083623.
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
K101212 · Medtronic, Inc. · Aug 2010
SJM ATTUNE ANNULOPLASTY RING
K092876 · St Jude Medical · Oct 2009
SEGUIN ANNULOPLASTY RING
K092310 · St Jude Medical · Aug 2009
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
K083191 · Edwards Lifesciences, LLC · Apr 2009
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
K083470 · Edwards Lifesciences, LLC · Jan 2009
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
K083835 · St Jude Medical · Jan 2009