Product code DTM— Cardiovascular
CAPIOX ARTERIAL FILTER
- Classification name
- Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Device class
- Class 2
- Regulation
- 21 CFR 870.4260
- Advisory panel
- Cardiovascular
- Total cleared
- 96
- First cleared
- Most recent
Market context for product code DTM
FDA has cleared devices under product code DTM between 1978 and 2026, filed by 38 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2024
- 2023
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2001
Top applicants under product code DTM
Recent clearances under product code DTM
- K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter
- K242953 — KIDS Arterial Filters
- K242092 — MICRO Arterial Filters
- K231362 — OCS Heart Leukocyte Depleting Filter
- K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
- K122760 — AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
- K121209 — TERUMO PALL AL20X ARTERIAL FILTER
- K112525 — D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
- K100646 — AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
- K093986 — AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
- K090518 — QUART ARTERIAL FILTER WITH SOFTLINE COATING
- K093601 — AF 840 PH.I.S.I.O. ARTERIAL FILTER
- K083747 — TERUMO PALL AL3X ARTERIAL FILTER
- K083834 — TERUMO PALL AL6X ARTERIAL FILTER
- K081054 — GISH ARTERIAL FILTER WITH HA COATING
- K082544 — QUART ARTERIAL FILTER WITH BIOLINE COATING
- K072308 — D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
- K071253 — AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
- K063255 — D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
- K062429 — MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
- K061546 — QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
- K052717 — D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
- K052205 — CAPIOX AF125X ARTERIAL FILTER
- K051232 — D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER
- K041061 — D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
- K040184 — DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
- K033987 — D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
- K033468 — AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
- K031946 — EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
- K031323 — DBT, DYNAMIC BUBBLE TRAP
- K032128 — TERUMO AL8X ARTERIAL FILTER WITH X-COATING
- K023833 — GISH ARTERIAL FILTER WITH GBS COATING
- K022071 — EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000
- K013084 — AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
- K011804 — CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
- K002493 — DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
- K002026 — CAPIOX ARTERIAL FILTER
- K001787 — QUART ARTERIAL FILTER, MODEL HBF 140
- K001138 — AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
- K000379 — MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
- K994208 — AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
- K982254 — COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
- K980762 — PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
- K961869 — DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
- K952532 — AFFINITY ARTERIAL BLOOD FILTER
- K952270 — DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN
- K943917 — CAPIOX ARTERIAL FILTER
- K945198 — DIDECO PEDIATRIC ARTERIAL FILTERS
- K926413 — MEDTRONIC ARTERIAL FILTER
- K914791 — GISH ARTERIAL FILTER
- K920594 — SHILEY PERFUSION TUBING SETS
- K910935 — MODIFIED PYROGEN TESTING
- K902723 — ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
- K902518 — LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE
- K900758 — HEPARINIZED ARTERIAL SCREEN BLOOD FILTER
- K892387 — MODIFIED GELMAN ARTERIAL FILTER
- K882137 — EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40
- K873316 — BUBBLE TRAP-FILTER CAT. NO B180F37
- K880671 — MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER
- K875080 — AIR VENT LINE CAT. NO. AVL-36
- K864262 — ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
- K862591 — INTERFACE ARTERIAL BLOOD FILTER, MODEL 42
- K862609 — INTERFACE ARTERIAL BLOOD FILTER, MODEL 44
- K862068 — GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)
- K855066 — SWANK ARTERIAL LINE BLOOD FILTER HF6000
- K853987 — PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE
- K851003 — ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
- K842813 — HEPARIN COATED ARTERIAL BLOOD FILTERS
- K834380 — PALL EC PLUS FILTER
- K834382 — PALL EC PLUS FILTER W/FILTER SLEEVE
- K840612 — PEDIATRIC ARTERIAL BLOOD FILTER
- K831507 — LOW TRAUMA ARTERIAL FILTER H-640
- K833476 — INTERSEPT 40 MICRON FILTER W/TUBING
- K833477 — INTERSEPT 40 MICRON FILTER
- K833048 — PURGES LINES, PL-45 & PL-33
- K830131 — ARTERIAL BLOOD FILTER AF-1025-AF-1025BL
- K830132 — ARTERIAL BLOOD FILTER AF-1040-AF-1040BL
- K823108 — INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT
- K823258 — INTERFACE ARTERIAL BLOOD FILTER #40
- K820044 — ARTERIAL BLOOD FILTER, #AF-1025
- K820343 — ARTERIAL BLOOD FILTER MODEL #AF-1040
- K820679 — PEDIATRIC ARTERIAL BLOOD FILTER #AF-540
- K820472 — WILLIAM HARVEY H-625 ARTERIAL FILTER
- K820045 — CARDIOVASCULAR DEVICES
- K812659 — TERUMO HOLLOW OXYGENATOR CIRCUIT
- K813131 — INTERFACE ARTERIAL BLOOD FILTER
- K812742 — SHILEY ARTERIAL FILTER W/40 MICRON SCREE
- K811379 — SHILEY ARTERIAL FILTER
- K810068 — PEDIATRIC ARTERIAL BLOOD FILTER
- K802755 — ARTERIAL BLOOD FILTER BF-37
- K802602 — L-3 PURGE LINE
- K801147 — PEDIATRIC ARTERIAL BLOOD FILTER #AF-5
- K792450 — ARTERIAL BLOOD FILTER, MODEL AF-10
- K791748 — ULTIPOR BLOOD FILTER EXTRA-CORPOREAL
- K790435 — INTERSEPT* BLOOD FILTER W/ TUBING BYPASS
- K781707 — FILTER, ARTERIAL BLOOD W/TUBING BYPASS
Data sourced from openFDA. This site is unofficial and independent of the FDA.