510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984322Substantially Equivalent

Dideco D920, Lilliput 1 Twin Reservoir

Dideco S.p.A., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984322 is the FDA 510(k) clearance record for DIDECO D920, LILLIPUT 1 TWIN RESERVOIR, a class II device, cleared for Dideco S.P.A. on under FDA product code DTP (Defoamer, Cardiopulmonary Bypass). FDA records list 33 510(k) clearances for Dideco S.P.A., from to . As of , FDA records show no recalls naming K984322.

Clearance record

Decision date
Received
(89 days to decision)
Product code
DTP Defoamer, Cardiopulmonary Bypass
Regulation
21 CFR 870.4230
Device class
Class II
Review panel
Cardiovascular
Applicant
Dideco S.P.A. 1601 Trapelo Rd., Waltham MA
510(k) summary
Summary
Third party review
No

Clearances, product code DTP

Trailing 12 months

FDA records hold no clearances under product code DTP in the trailing twelve months.

FDA records show no clearances under product code DTP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260