Cleared Special

K013084 - AFFINITY 38 MICON ARTERIAL FILTER WITH ...

K013084 is the FDA 510(k) clearance for AFFINITY 38 MICON ARTERIAL FILTER WITH ... by Medtronic Perfusion Systems. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Special 510(k) pathway after a 13-day FDA review.

K013084 · Medtronic Perfusion Systems · Cardiovascular device
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Sep 2001
Decision
13d
Days
Class 2
Risk

K013084 is an FDA 510(k) clearance for the AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on September 27, 2001 after a review of 13 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 Medtronic Perfusion Systems devices

Submission Details

510(k) Number K013084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2001
Decision Date September 27, 2001
Days to Decision 13 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
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 59
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K013084.
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
K031946 · Edwards Lifesciences, LLC · Nov 2003
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K032128 · Terumo Cardiovascular Systems Corp. · Aug 2003
GISH ARTERIAL FILTER WITH GBS COATING
K023833 · Gish Biomedical, Inc. · Mar 2003
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804 · Terumo Cardiovascular Systems Corp. · Jul 2001
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
K002493 · Cobe Cardiovascular, Inc. · Nov 2000
CAPIOX ARTERIAL FILTER
K002026 · Terumo Medical Corp. · Sep 2000