DTM · Class II · 21 CFR 870.4260

FDA Product Code DTM: Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Under FDA product code DTM, arterial line blood filters for cardiopulmonary bypass are cleared to remove particulate and gaseous emboli from the arterial perfusion line.

These microporous filters are placed in the arterial line of the heart-lung machine to capture microemboli — including air bubbles, fat particles, and cellular debris — before they enter the patient's circulation, reducing the risk of stroke and organ injury during cardiac surgery.

DTM devices are Class II medical devices, regulated under 21 CFR 870.4260 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Bentley Laboratories, Inc., Sorin Group Italia S.R.L. and Pall Biomedical Products Co..

96
Total
96
Cleared
99d
Avg days
1978
Since
96 devices
25–48 of 96
Cleared Jan 08, 2004
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
K033987
Dideco S.P.A.
Cardiovascular · 16d
Cleared Nov 14, 2003
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
K033468
Medtronic Perfusion Systems
Cardiovascular · 11d
Cleared Nov 03, 2003
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
K031946
Edwards Lifesciences, LLC
Cardiovascular · 132d
Cleared Aug 01, 2003
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
K032128
Terumo Cardiovascular Systems Corp.
Cardiovascular · 22d
Cleared Mar 31, 2003
GISH ARTERIAL FILTER WITH GBS COATING
K023833
Gish Biomedical, Inc.
Cardiovascular · 133d
Cleared Sep 27, 2001
AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
K013084
Medtronic Perfusion Systems
Cardiovascular · 13d
Cleared Jul 09, 2001
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Nov 30, 2000
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
K002493
Cobe Cardiovascular, Inc.
Cardiovascular · 108d
Cleared Sep 06, 2000
CAPIOX ARTERIAL FILTER
K002026
Terumo Medical Corp.
Cardiovascular · 65d
Cleared Apr 27, 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
K001138
Medtronic Vascular
Cardiovascular · 17d
Cleared Feb 16, 2000
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
K000379
Medtronic Vascular
Cardiovascular · 9d
Cleared Jan 13, 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
K994208
Medtronic Perfusion Systems
Cardiovascular · 30d
Cleared Sep 10, 1998
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
K982254
Cobe Cardiovascular, Inc.
Cardiovascular · 76d
Cleared Sep 01, 1998
PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
K980762
Pall Corp.
Cardiovascular · 186d
Cleared Aug 12, 1996
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
K961869
Sorin Biomedical, Inc.
Cardiovascular · 89d
Cleared Jul 25, 1995
CAPIOX ARTERIAL FILTER
K943917
Terumo Medical Corp.
Cardiovascular · 348d
Cleared Aug 24, 1993
MEDTRONIC ARTERIAL FILTER
K926413
Medtronic Vascular
Cardiovascular · 244d
Cleared Apr 06, 1993
GISH ARTERIAL FILTER
K914791
Gish Biomedical, Inc.
Cardiovascular · 531d
Cleared Mar 18, 1993
SHILEY PERFUSION TUBING SETS
K920594
Shiley, Inc.
Cardiovascular · 401d
Cleared May 16, 1991
MODIFIED PYROGEN TESTING
K910935
Electromedics, Inc.
Cardiovascular · 91d
Cleared Dec 13, 1990
ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
K902723
Electromedics, Inc.
Cardiovascular · 177d
Cleared Oct 16, 1990
LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE
K902518
Pall Biomedical Products Co.
Cardiovascular · 132d
Cleared May 17, 1990
HEPARINIZED ARTERIAL SCREEN BLOOD FILTER
K900758
Cobe Laboratories, Inc.
Cardiovascular · 90d
Cleared Jun 22, 1989
MODIFIED GELMAN ARTERIAL FILTER
K892387
Gelman Sciences, Inc.
Toxicology · 69d