QUART ARTERIAL FILTER WITH SOFTLINE COATING— 510(k) K090518

Name: FDA 510(k) clearance K090518
Creator: U.S. Food and Drug Administration
Published: 2009-12-18

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K090518 for QUART ARTERIAL FILTER WITH SOFTLINE COATING, Substantially Equivalent on 2009-12-18. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2009-02-26
Decision date: 2009-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Hirrlingen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTM

view all

K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter2026-01-16
K242953 — KIDS Arterial Filters2024-12-20
K242092 — MICRO Arterial Filters2024-11-18
K231362 — OCS Heart Leukocyte Depleting Filter2023-10-31
K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE2013-03-19

More clearances from Maquet Cardiopulmonary, AG

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.