Cleared Traditional

K062429 - MODIFICATION TO EMBOL-X INTRA-AORTIC FI...

K062429 is the FDA 510(k) clearance for MODIFICATION TO EMBOL-X INTRA-AORTIC FI... by Edwards Lifesciences Research Medical. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K062429 · Edwards Lifesciences Research Medical · Cardiovascular device
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Sep 2006
Decision
37d
Days
Class 2
Risk

K062429 is an FDA 510(k) clearance for the MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X.... Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Edwards Lifesciences Research Medical (Midvale, US). The FDA issued a Cleared decision on September 27, 2006 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - 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 Edwards Lifesciences Research Medical devices

Submission Details

510(k) Number K062429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2006
Decision Date September 27, 2006
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 59
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K062429.
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
K072308 · Sorin Group Italia S.R.L. · Sep 2007
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
K071253 · Medtronic Vascular · Jul 2007
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
K063255 · Sorin Group Italia S.R.L. · Jan 2007
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
K061546 · Maquet Cardiopulmonary, AG · Jun 2006
CAPIOX AF125X ARTERIAL FILTER
K052205 · Terumo Cardiovascular Systems Corp. · Sep 2005
DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
K040184 · Cobe Cardiovascular, Inc. · Feb 2004