AFFINITY CVR— 510(k) K936003

Name: FDA 510(k) clearance K936003
Creator: U.S. Food and Drug Administration
Published: 1994-06-20

Substantially Equivalent

Avecor Cardiovascular, Inc.

FDA 510(k) clearance K936003 for AFFINITY CVR, Substantially Equivalent on 1994-06-20. Applicant: Avecor Cardiovascular, Inc.. Device class: 2.

Clearance details

Applicant: Avecor Cardiovascular, Inc.
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1993-12-16
Decision date: 1994-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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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
K952532 — AFFINITY ARTERIAL BLOOD FILTER1995-10-06
K940126 — AVECOR PRE-BYPASS FILTER1994-06-28

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K936003

K-number listed on FDA's recall record

Z-0645-2018 — Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.Class II·Terminated·Medtronic Perfusion Systems·20180116

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K936003.

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