Atlas FDA

FIQ

23 FDA 510(k) clearances · Product code

34 daysmedian time to decision
101 days90th percentile
23clearances measured

FDA profile

Official device name
Cannula, A-V Shunt
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Medical specialty
Gastroenterology, Urology
Flags
Implant
Adverse events (MAUDE)
2000: 1 · 2001: 1 · 2004: 1 · 2006: 2 · 2007: 4 · 2008: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA (K892887)Akcess Medical Products, Inc.1989-05-15
S-100 ALLEN-BROWN SHUNT (K892663)Akcess Medical Products, Inc.1989-05-04
SAF-T-SHUNT, S-300 SERIES (K892666)Akcess Medical Products, Inc.1989-05-04
PEDIATRIC SIZED HEMOCATH CATHETER (K844692)Quinton, Inc.1985-01-18
PLUME FISTULA NEEDLE (K841791)Hospal Medical Corp.1984-07-09
HEMOFILTRATION CATHETER HF-100 (K840322)Vas-Cath of Canada , Ltd.1984-04-24
HEMOCATH (K840415)Quinton, Inc.1984-04-20
PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA (K834358)Vas-Cath of Canada , Ltd.1984-04-02
HEMASITE/RENALOY -VASCULAR ACCESS SHUNT (K840436)Renal Systems, Inc.1984-02-21
RENALLOY HEMASITE VASCULAR ACCESS SHUNT (K833622)Renal Systems, Inc.1983-11-29
HEMOCLAV VENOUS CATHETER (K831801)Exo, Inc.1983-07-07
SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS (K831401)Med-West, Inc.1983-06-03
SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 (K831440)Med-West, Inc.1983-06-03
EXTRACORPOREAL SUBCLAVIAN CATHETER KIT (K823752)Extracorporeal Medical Specialities, Inc.1983-01-14
ARTERIO VENOUS SHUNT CANNULA & ADAPTORS (K822880)Renal Systems, Inc.1982-10-18
HEMASITE VASCULAR ACCESS SHUNT HM-1000 (K813237)Renal Systems, Inc.1981-11-30
HEMASITE GRAFTLESS VASCULAR ACESS (K812890)Renal Systems, Inc.1981-11-16
HEMASITE VASCULAR ACCESS SHUNT (K811384)Renal Systems, Inc.1981-07-31
VASCULAR ACCESS SYSTEM (K810114)Bentley Laboratories, Inc.1981-03-26
SSC8 SORENSON SUBCLAVIAN CATHETER (K801478)Sorensen Research1980-08-27
ULDALL SUBCLAVIAN CANNULA SC-100 (K791308)Vas-Cath of Canada , Ltd.1979-08-03
SILASTIC BRAND PENILE IMPLANT (K780484)Dow Corning Corp. Healthcare Industries Materials1978-07-17
HEMODIALYSIS CANNULA & FEMORAL CLAMP (K760973)Rodell Medical, Inc.1977-01-12

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