510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261644Substantially Equivalent

Perfadex Plus

Xvivo Perfusion, Inc., Mölndal, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261644 is the FDA 510(k) clearance record for Perfadex Plus, a class II device, cleared for Xvivo Perfusion AB on under FDA product code KDN (System, Perfusion, Kidney). FDA records list 4 510(k) clearances for Xvivo Perfusion AB, from to . As of , FDA records show no recalls naming K261644.

Clearance record

Decision date
Received
(66 days to decision)
Product code
KDN System, Perfusion, Kidney
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Xvivo Perfusion AB Entreprenörsstråket 10, Mölndal, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KDN

Trailing 12 months
3 clearances under product code KDN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KDN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260