510(k) Report

FDA applicant

Avecor Cardiovascular, Inc.

Plymouth, MN9 decisions1993–19986 recalls

FDA records 9 decisions for Avecor Cardiovascular, Inc. (Plymouth, MN) from 1993 to 1998: 9 510(k) clearances. Most are in product codes DTN (Reservoir, Blood, Cardiopulmonary Bypass) and DTZ (Oxygenator, Cardiopulmonary Bypass). 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Avecor Cardiovascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Avecor Cardiovascular, Inc. since 2007.

Recalls per year

1in 2019

2007: 12016: 22018: 12019: 1
2007high 2 (2016) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Avecor Cardiovascular, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DTNReservoir, Blood, Cardiopulmonary Bypass3decisions
  • DTZOxygenator, Cardiopulmonary Bypass2decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision
  • DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass1decision
  • KRJFilter, Prebypass, Cardiopulmonary Bypass1decision
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line1decision

Who builds on its devices?

Later devices cite its devices 25 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K973760Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceAvecor Cardiovascular, Inc. · 199811cite it
  • K932252Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 19933cite it
  • K936003Affinity CVRAvecor Cardiovascular, Inc. · 19943cite it
  • K952532Affinity Arterial Blood FilterAvecor Cardiovascular, Inc. · 19953cite it
  • K971105Myotherm (TM) XP Cardioplegia Delivery SystemAvecor Cardiovascular, Inc. · 19972cite it
  • K935717Affinity Venous Reservior BagAvecor Cardiovascular, Inc. · 19942cite it

What has FDA decided for it lately?

  • K973760Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceAvecor Cardiovascular, Inc. · 19982 recalls
  • K964017Affinity Blood Pump SystemAvecor Cardiovascular, Inc. · 1997
  • K971105Myotherm (TM) XP Cardioplegia Delivery SystemAvecor Cardiovascular, Inc. · 1997
  • K952532Affinity Arterial Blood FilterAvecor Cardiovascular, Inc. · 19951 recall
  • K940126Avecor Pre-Bypass FilterAvecor Cardiovascular, Inc. · 1994
  • K936003Affinity CVRAvecor Cardiovascular, Inc. · 19943 recalls
  • K935717Affinity Venous Reservior BagAvecor Cardiovascular, Inc. · 1994
  • K932252Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993

All 9 as Avecor Cardiovascular, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K952532Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351Nov 14, 2019Class II
  • K936003Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY…Jan 16, 2018Class II
  • K132972Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion…Nov 16, 2016Class II
  • K012538Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems…Feb 4, 2016Class III
  • K936003Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma…Oct 1, 2007
  • K936003Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous…Mar 25, 2004