Cleared Special

K082544 - QUART ARTERIAL FILTER WITH BIOLINE COATING

K082544 is the FDA 510(k) clearance for QUART ARTERIAL FILTER WITH BIOLINE COATING by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Special 510(k) pathway after a 30-day FDA review.

K082544 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Oct 2008
Decision
30d
Days
Class 2
Risk

K082544 is an FDA 510(k) clearance for the QUART ARTERIAL FILTER WITH BIOLINE COATING. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on October 3, 2008 after a review of 30 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. 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 Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K082544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2008
Decision Date October 03, 2008
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 56
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K082544.
TERUMO PALL AL3X ARTERIAL FILTER
K083747 · Terumo Cardiovascular Systems Corp. · Aug 2009
TERUMO PALL AL6X ARTERIAL FILTER
K083834 · Terumo Cardiovascular Systems Corp. · Apr 2009
GISH ARTERIAL FILTER WITH HA COATING
K081054 · Gish Biomedical, Inc. · Jan 2009
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