510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K004001Substantially Equivalent

Monolyth Mimesys Hollow Fiber Oxygenator

Dideco S.p.A., Arvada CO / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K004001 is the FDA 510(k) clearance record for MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR, a class II device, cleared for Dideco on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 33 510(k) clearances for Dideco, from to . As of , FDA records show no recalls naming K004001.

Clearance record

Decision date
Received
(282 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
Dideco 14401 W. 65th Way, Arvada CO
510(k) summary
Summary
Third party review
No

Clearances, product code DTZ

Trailing 12 months
5 clearances under product code DTZ in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DTZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260