Atlas FDA

KDK

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Container, Transport, Kidney
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5880
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
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RecordFirmDate
RM3 RENAL PRESERVATION SYSTEM (K053169)Waters Instruments, Inc.2006-01-17
HYPOTRANS MODEL 750 (K911577)Martin Mclane Medical1992-07-08
KEITHLEY LYMPHOCYTE DEPLETION CART (K801899)Keithley Development Co.1980-09-26

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Every clearance here is in the API, with alerts when new ones post.