ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER— 510(k) K014016

Name: FDA 510(k) clearance K014016
Creator: U.S. Food and Drug Administration
Published: 2002-02-01

Substantially Equivalent

Minntech Corp.

FDA 510(k) clearance K014016 for ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER, Substantially Equivalent on 2002-02-01. Applicant: Minntech Corp.. Device class: 2.

Clearance details

Applicant: Minntech Corp.
Product code: Code DWC
Device class: Class 2
Regulation: 21 CFR 870.4250
Advisory panel: Cardiovascular
Date received: 2001-12-05
Decision date: 2002-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWC

view all

K220635 — Heater-Cooler System 3T2022-11-16
K212657 — Quantum Heater-Cooler2022-05-06
K191402 — Heater-Cooler System 3T2020-02-25
K140012 — SORIN FLEXTHERM2014-01-31
K130300 — HEATER-COOLER UNIT HCU 402013-07-01

More clearances from Minntech Corp.

view all

K120306 — RAPICIDE OPA-282012-09-27
K092387 — MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM2010-04-05
K071298 — HF JUNIOR HEMOFILTER2007-08-08
K050952 — HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR2006-01-31
K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM2004-04-27

Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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 →

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