Cleared Traditional

K926413 - MEDTRONIC ARTERIAL FILTER

K926413 is an FDA 510(k) clearance for MEDTRONIC ARTERIAL FILTER, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K926413 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
244d
Days
Class 2
Risk

K926413 is an FDA 510(k) clearance for the MEDTRONIC ARTERIAL FILTER. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on August 24, 1993 after a review of 244 days - an extended review 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: 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K926413

510(k) Number K926413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date August 24, 1993
Days to Decision 244 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
119d slower than avg
Panel avg: 125d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTM Device Classification - Class 2, Special Controls

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 86
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K926413.
PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
K980762 · Pall Corp. · Sep 1998
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
K961869 · Sorin Biomedical, Inc. · Aug 1996
CAPIOX ARTERIAL FILTER
K943917 · Terumo Medical Corp. · Jul 1995
GISH ARTERIAL FILTER
K914791 · Gish Biomedical, Inc. · Apr 1993
SHILEY PERFUSION TUBING SETS
K920594 · Shiley, Inc. · Mar 1993
MODIFIED PYROGEN TESTING
K910935 · Electromedics, Inc. · May 1991