AFFINITY ARTERIAL BLOOD FILTER— 510(k) K952532

Name: FDA 510(k) clearance K952532
Creator: U.S. Food and Drug Administration
Published: 1995-10-06

Substantially Equivalent

Avecor Cardiovascular, Inc.

FDA 510(k) clearance K952532 for AFFINITY ARTERIAL BLOOD FILTER, Substantially Equivalent on 1995-10-06. Applicant: Avecor Cardiovascular, Inc.. Device class: 2.

Clearance details

Applicant: Avecor Cardiovascular, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1995-06-01
Decision date: 1995-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTM

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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 Avecor Cardiovascular, Inc.

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K973760 — AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE1998-02-18
K964017 — AFFINITY BLOOD PUMP SYSTEM1997-08-05
K971105 — MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM1997-07-11
K940126 — AVECOR PRE-BYPASS FILTER1994-06-28
K936003 — AFFINITY CVR1994-06-20

Recalls naming K952532

K-number listed on FDA's recall record

Z-0693-2020 — Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351Class II·Terminated·Medtronic Perfusion Systems·20191114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K952532.

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