FDA Product Code
FDA Product Code DTM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4260
510(k) Clearances — 96 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | Medtronic | 2026-01-16 | Special | PDF ↗ |
| K242953 | KIDS Arterial Filters | Sorin Group Italia S.R.L. | 2024-12-20 | Special | PDF ↗ |
| K242092 | MICRO Arterial Filters | Sorin Group Italia S.R.L. | 2024-11-18 | Special | PDF ↗ |
| K231362 | OCS Heart Leukocyte Depleting Filter | TransMedics, Inc. | 2023-10-31 | Traditional | PDF ↗ |
| K123351 | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | Medtronic Perfusion Systems | 2013-03-19 | Traditional | PDF ↗ |
| K122760 | AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2012-12-07 | Traditional | PDF ↗ |
| K121209 | TERUMO PALL AL20X ARTERIAL FILTER | Terumo Cardiovascular Systems Corporation | 2012-05-08 | Special | PDF ↗ |
| K112525 | D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS | Parexel International | 2011-09-29 | Special | PDF ↗ |
| K100646 | AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2010-12-16 | Traditional | PDF ↗ |
| K093986 | AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS | Sorin Group Italia S.R.L. | 2010-01-22 | Special | PDF ↗ |
| K093601 | AF 840 PH.I.S.I.O. ARTERIAL FILTER | Sorin Group Italia S.R.L. | 2009-12-18 | Special | PDF ↗ |
| K090518 | QUART ARTERIAL FILTER WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | 2009-12-18 | Special | PDF ↗ |
| K083747 | TERUMO PALL AL3X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | 2009-08-20 | Traditional | PDF ↗ |
| K083834 | TERUMO PALL AL6X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | 2009-04-17 | Traditional | PDF ↗ |
| K081054 | GISH ARTERIAL FILTER WITH HA COATING | Gish Biomedical, Inc. | 2009-01-15 | Traditional | PDF ↗ |
| K082544 | QUART ARTERIAL FILTER WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2008-10-03 | Special | PDF ↗ |
| K072308 | D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED | Sorin Group Italia S.R.L. | 2007-09-12 | Special | PDF ↗ |
| K071253 | AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 | Medtronic Vascular | 2007-07-03 | Traditional | PDF ↗ |
| K063255 | D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED | Sorin Group Italia S.R.L. | 2007-01-11 | Traditional | PDF ↗ |
| K062429 | MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH | Edwards Lifesciences Research Medical | 2006-09-27 | Traditional | PDF ↗ |
| K061546 | QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 | Maquet Cardiopulmonary, AG | 2006-06-20 | Special | PDF ↗ |
| K052717 | D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER | Dideco S.R.L. | 2005-10-20 | Special | PDF ↗ |
| K052205 | CAPIOX AF125X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | 2005-09-12 | Traditional | PDF ↗ |
| K051232 | D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER | Dideco S.R.L. | 2005-05-20 | Special | PDF ↗ |
| K041061 | D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS | Dideco S.P.A. | 2004-05-06 | Special | PDF ↗ |
| K040184 | DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER | Cobe Cardiovascular, Inc. | 2004-02-26 | Special | PDF ↗ |
| K033987 | D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS | Dideco S.P.A. | 2004-01-08 | Special | PDF ↗ |
| K033468 | AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE | Medtronic Perfusion Systems | 2003-11-14 | Special | PDF ↗ |
| K031946 | EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE | Edwards Lifesciences, LLC | 2003-11-03 | Traditional | PDF ↗ |
| K031323 | DBT, DYNAMIC BUBBLE TRAP | Convergenza AG | 2003-08-01 | Abbreviated | PDF ↗ |
| K032128 | TERUMO AL8X ARTERIAL FILTER WITH X-COATING | Terumo Cardiovascular Systems Corp. | 2003-08-01 | Traditional | PDF ↗ |
| K023833 | GISH ARTERIAL FILTER WITH GBS COATING | Gish Biomedical, Inc. | 2003-03-31 | Traditional | PDF ↗ |
| K022071 | EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 | Embol-X, Inc. | 2003-02-14 | Traditional | PDF ↗ |
| K013084 | AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T | Medtronic Perfusion Systems | 2001-09-27 | Special | PDF ↗ |
| K011804 | CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X | Terumo Cardiovascular Systems Corp. | 2001-07-09 | Special | PDF ↗ |
| K002493 | DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER | Cobe Cardiovascular, Inc. | 2000-11-30 | Traditional | PDF ↗ |
| K002026 | CAPIOX ARTERIAL FILTER | Terumo Medical Corp. | 2000-09-06 | Traditional | PDF ↗ |
| K001787 | QUART ARTERIAL FILTER, MODEL HBF 140 | Jostra Medizintechnik AG | 2000-06-30 | Traditional | PDF ↗ |
| K001138 | AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 | Medtronic Vascular | 2000-04-27 | Special | PDF ↗ |
| K000379 | MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 | Medtronic Vascular | 2000-02-16 | Special | PDF ↗ |
| K994208 | AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 | Medtronic Perfusion Systems | 2000-01-13 | Special | PDF ↗ |
| K982254 | COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD | Cobe Cardiovascular, Inc. | 1998-09-10 | Abbreviated | PDF ↗ |
| K980762 | PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE | Pall Corp. | 1998-09-01 | Traditional | PDF ↗ |
| K961869 | DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 | Sorin Biomedical, Inc. | 1996-08-12 | Traditional | PDF ↗ |
| K952532 | AFFINITY ARTERIAL BLOOD FILTER | Avecor Cardiovascular, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K952270 | DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN | Sorin Biomedical, Inc. | 1995-08-21 | Traditional | PDF ↗ |
| K943917 | CAPIOX ARTERIAL FILTER | Terumo Medical Corp. | 1995-07-25 | Traditional | PDF ↗ |
| K945198 | DIDECO PEDIATRIC ARTERIAL FILTERS | Sorin Biomedical, Inc. | 1995-06-27 | Traditional | PDF ↗ |
| K926413 | MEDTRONIC ARTERIAL FILTER | Medtronic Vascular | 1993-08-24 | Traditional | PDF ↗ |
| K914791 | GISH ARTERIAL FILTER | Gish Biomedical, Inc. | 1993-04-06 | Traditional | PDF ↗ |
| K920594 | SHILEY PERFUSION TUBING SETS | Shiley, Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K910935 | MODIFIED PYROGEN TESTING | Electromedics, Inc. | 1991-05-16 | Traditional | PDF ↗ |
| K902723 | ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 | Electromedics, Inc. | 1990-12-13 | Traditional | PDF ↗ |
| K902518 | LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE | Pall Biomedical Products Co. | 1990-10-16 | Traditional | PDF ↗ |
| K900758 | HEPARINIZED ARTERIAL SCREEN BLOOD FILTER | Cobe Laboratories, Inc. | 1990-05-17 | Traditional | PDF ↗ |
| K892387 | MODIFIED GELMAN ARTERIAL FILTER | Gelman Sciences, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K882137 | EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 | Medtronic Blood Systems, Inc. | 1988-08-12 | Traditional | PDF ↗ |
| K873316 | BUBBLE TRAP-FILTER CAT. NO B180F37 | American Omni Medical, Inc. | 1988-07-14 | Traditional | PDF ↗ |
| K880671 | MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER | Medtronic Blood Systems, Inc. | 1988-05-06 | Traditional | PDF ↗ |
| K875080 | AIR VENT LINE CAT. NO. AVL-36 | American Omni Medical, Inc. | 1988-02-29 | Traditional | PDF ↗ |
| K864262 | ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING | Johnson & Johnson Professionals, Inc. | 1987-01-02 | Traditional | PDF ↗ |
| K862591 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 | Medical, Inc. | 1986-09-04 | Traditional | PDF ↗ |
| K862609 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 | Medical, Inc. | 1986-09-04 | Traditional | PDF ↗ |
| K862068 | GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) | Gelman Sciences, Inc. | 1986-08-08 | Traditional | PDF ↗ |
| K855066 | SWANK ARTERIAL LINE BLOOD FILTER HF6000 | Cobe Laboratories, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K853987 | PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE | Pall Biomedical Products Co. | 1985-12-11 | Traditional | PDF ↗ |
| K851003 | ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX | Gish Biomedical, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K842813 | HEPARIN COATED ARTERIAL BLOOD FILTERS | American Bentley | 1985-01-08 | Traditional | PDF ↗ |
| K834382 | PALL EC PLUS FILTER W/FILTER SLEEVE | Pall Biomedical Products Co. | 1984-08-03 | Traditional | PDF ↗ |
| K834380 | PALL EC PLUS FILTER | Pall Biomedical Products Co. | 1984-08-03 | Traditional | PDF ↗ |
| K840612 | PEDIATRIC ARTERIAL BLOOD FILTER | American Bentley | 1984-04-17 | Traditional | PDF ↗ |
| K831507 | LOW TRAUMA ARTERIAL FILTER H-640 | C.R. Bard, Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K833476 | INTERSEPT 40 MICRON FILTER W/TUBING | Extracorporeal Medical Specialities, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K833477 | INTERSEPT 40 MICRON FILTER | Extracorporeal Medical Specialities, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K833048 | PURGES LINES, PL-45 & PL-33 | American Bentley | 1983-10-20 | Traditional | PDF ↗ |
| K830131 | ARTERIAL BLOOD FILTER AF-1025-AF-1025BL | American Bentley | 1983-01-28 | Traditional | PDF ↗ |
| K830132 | ARTERIAL BLOOD FILTER AF-1040-AF-1040BL | American Bentley | 1983-01-28 | Traditional | PDF ↗ |
| K823108 | INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT | Extracorporeal Medical Specialities, Inc. | 1982-11-30 | Traditional | PDF ↗ |
| K823258 | INTERFACE ARTERIAL BLOOD FILTER #40 | Medical, Inc. | 1982-11-24 | Traditional | PDF ↗ |
| K820044 | ARTERIAL BLOOD FILTER, #AF-1025 | Bentley Laboratories, Inc. | 1982-06-29 | Traditional | PDF ↗ |
| K820679 | PEDIATRIC ARTERIAL BLOOD FILTER #AF-540 | Bentley Laboratories, Inc. | 1982-06-17 | Traditional | PDF ↗ |
| K820343 | ARTERIAL BLOOD FILTER MODEL #AF-1040 | Bentley Laboratories, Inc. | 1982-06-17 | Traditional | PDF ↗ |
| K820472 | WILLIAM HARVEY H-625 ARTERIAL FILTER | C.R. Bard, Inc. | 1982-03-15 | Traditional | PDF ↗ |
| K820045 | CARDIOVASCULAR DEVICES | Bentley Laboratories, Inc. | 1982-01-29 | Traditional | PDF ↗ |
| K812659 | TERUMO HOLLOW OXYGENATOR CIRCUIT | Terumo Medical Corp. | 1981-12-14 | Traditional | PDF ↗ |
| K813131 | INTERFACE ARTERIAL BLOOD FILTER | Medical, Inc. | 1981-11-27 | Traditional | PDF ↗ |
| K812742 | SHILEY ARTERIAL FILTER W/40 MICRON SCREE | Shiley, Inc. | 1981-11-02 | Traditional | PDF ↗ |
| K811379 | SHILEY ARTERIAL FILTER | Shiley, Inc. | 1981-06-09 | Traditional | PDF ↗ |
| K810068 | PEDIATRIC ARTERIAL BLOOD FILTER | Delta Medical Industries | 1981-01-22 | Traditional | PDF ↗ |
| K802755 | ARTERIAL BLOOD FILTER BF-37 | Delta Medical Industries | 1981-01-07 | Traditional | PDF ↗ |
| K802602 | L-3 PURGE LINE | Delta Medical Industries | 1980-11-12 | Traditional | PDF ↗ |
| K801147 | PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 | Bentley Laboratories, Inc. | 1980-06-04 | Traditional | PDF ↗ |
| K792450 | ARTERIAL BLOOD FILTER, MODEL AF-10 | Bentley Laboratories, Inc. | 1979-12-19 | Traditional | PDF ↗ |
| K791748 | ULTIPOR BLOOD FILTER EXTRA-CORPOREAL | Pall Biomedical Products Co. | 1979-10-02 | Traditional | PDF ↗ |
| K790435 | INTERSEPT* BLOOD FILTER W/ TUBING BYPASS | Surgikos, Inc. | 1979-03-27 | Traditional | PDF ↗ |
| K781707 | FILTER, ARTERIAL BLOOD W/TUBING BYPASS | Surgikos, Inc. | 1978-10-26 | Traditional | PDF ↗ |
Product code DTM · Class II · Cardiovascular. Data: openFDA.