MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR— 510(k) K004001

Clearance details

Applicant

Dideco

Product code

Code DTZ

Device class

Class 2

Regulation

21 CFR 870.4350

Advisory panel

Cardiovascular

Date received

2000-12-26

Decision date

2001-10-04

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Arvada, CO, US

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• K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E22024-09-12

• K010478 — DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR2001-09-27
• K001388 — DATA MASTER PERFUSION MONITORING SYSTEM2000-07-28
• K936220 — DIDECO VACUUM PUMP1995-01-27
• K940519 — DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM1995-01-19

Death

182

Injury

422

Malfunction

3,636

Total

4,240

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 →