FDA.reportPublic FDA data

510(k) K231362

Device
OCS Heart Leukocyte Depleting Filter
Applicant
TransMedics, Inc.
510(k) number
K231362
Product code
DTM
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-31
Date received
2023-05-11
Regulation
870.4260
Classification name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Miriam Provost
Address
200 Minuteman Rd. Suite 302 Andover MA US 01810 01810

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DTM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronic2026-01-16
K242953KIDS Arterial FiltersSorin Group Italia S.R.L.2024-12-20
K242092MICRO Arterial FiltersSorin Group Italia S.R.L.2024-11-18
K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion Systems2013-03-19
K122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, Inc.2012-12-07
K121209TERUMO PALL AL20X ARTERIAL FILTERTerumo Cardiovascular Systems Corporation2012-05-08
K112525D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERSParexel International2011-09-29
K100646AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, Inc.2010-12-16
K093986AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERSSorin Group Italia S.R.L.2010-01-22
K093601AF 840 PH.I.S.I.O. ARTERIAL FILTERSorin Group Italia S.R.L.2009-12-18
K090518QUART ARTERIAL FILTER WITH SOFTLINE COATINGMaquet Cardiopulmonary, AG2009-12-18
K083747TERUMO PALL AL3X ARTERIAL FILTERTerumo Cardiovascular Systems Corp.2009-08-20
K083834TERUMO PALL AL6X ARTERIAL FILTERTerumo Cardiovascular Systems Corp.2009-04-17
K081054GISH ARTERIAL FILTER WITH HA COATINGGish Biomedical, Inc.2009-01-15
K082544QUART ARTERIAL FILTER WITH BIOLINE COATINGMaquet Cardiopulmonary, AG2008-10-03