510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081997Substantially Equivalent

Perfadex with Tham

Vitrolife Sweden AB, Kungsbacka, SE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081997 is the FDA 510(k) clearance record for PERFADEX WITH THAM, a class II device, cleared for Vitrolife Sweden AB on under FDA product code MSB (System And Accessories, Isolated Heart, Transport And Preservation). FDA records list 38 510(k) clearances for Vitrolife Sweden AB, from to . As of , FDA records show one recall naming K081997.

Clearance record

Decision date
Received
(87 days to decision)
Product code
MSB System And Accessories, Isolated Heart, Transport And Preservation
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vitrolife Sweden AB Faktorvagen 13, Kungsbacka, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSB

Trailing 12 months
1 clearance under product code MSB in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MSB, 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 20261
October 20260