510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020997Substantially Equivalent

Apex Ph.i.s.i.o. Adult Hollow Fiber Membrane Oxygenator

Dideco S.p.A., Waltham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020997 is the FDA 510(k) clearance record for APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR, a class II device, cleared for Dideco S.P.A. on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 33 510(k) clearances for Dideco S.P.A., from to . As of , FDA records show 2 recalls naming K020997.

Clearance record

Decision date
Received
(7 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
Dideco S.P.A. 195 W. St., Waltham MA
510(k) summary
Summary PDF
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