Atlas FDA

KNZ

10 FDA 510(k) clearances · Product code

36 daysmedian time to decision
253 days90th percentile
10clearances measured

FDA profile

Official device name
Accessories, A-V Shunt
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Medical specialty
Gastroenterology, Urology
Flags
Implant
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RecordFirmDate
ARGON DUAL LUMEN HEMODIALYSIS, CATHETER (K842039)Argon Medical Corp.1985-01-29
ACUTE HEMODIALYSIS TRAYS (K844612)Packaging Technologies, Inc.1984-12-17
VACCESS FEMORAL CANNULA (K842864)Vas-Cath of Canada , Ltd.1984-08-08
DUO FLOW CATHETER-MC 54 (K842416)Medical Components, Inc.1984-07-26
DOUBLE LUMEN SUBLCAVIAN-FEMORAL (K841530)Medical Components, Inc.1984-06-25
TOPS DISPOS. INFUSION SET/HEMODIALYSIS (K841119)Top Surgical Manufacturers Co.1984-04-20
HEMOCATH REPAIR KIT (K840424)Quinton, Inc.1984-03-05
HEMASITE ACCESSORIES MODIFICATION (K840437)Renal Systems, Inc.1984-02-21
RENAFLO AVF SET FOR HEMODIALYSIS (K834510)Renal Systems, Inc.1984-02-04
ACUTE HEMODIALYSIS TRAYS (K833139)Intermed, Inc.1983-12-22

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