Atlas FDA

DQR

25 FDA 510(k) clearances · Product code

83 daysmedian time to decision
212 days90th percentile
25clearances measured

FDA profile

Official device name
Cannula, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1300
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 75 · 2017: 29 · 2018: 16 · 2019: 16 · 2022: 27 · 2023: 36
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES (K131446)Integra LifeSciences Corporation2013-10-28
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II (K073559)Edwards Lifesciences Research Medical2008-01-31
ANGIODYNAMICS, INC., MICRO ACCESS KITS (K051655)AngioDynamics, Inc.2005-09-12
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 (K030398)Cardiacassist, Inc.2003-05-23
RMI INTERNAL MAMMARY ARTERY CANNULA (K960098)Research Medical, Inc.1996-03-26
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT (K902674)Datascope Corp.1991-01-16
MODIFIED SHILEY FEMORAL VENOUS CANNULA (K894784)Shiley, Inc.1990-03-28
RMI ARTERIAL PERFUSION CANNULA (K894243)Research Medical, Inc.1989-09-19
HARBORIN CENTRAL VENOUS CATHETER (K884628)Harbor Medical Devices, Inc.1989-05-15
DAIG COLLAPSIBLE STERILE SLEEVE (K884478)Daig Corp.1989-02-22
TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER (K884375)Argon Medical Corp.1989-01-11
ASK-300 (K882977)Medical Repackers Co.1989-01-05
HARBOR CENTRAL VENOUS CATHETER (K881884)Harbor Medical Devices, Inc.1988-07-28
MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM (K880771)Medsurg Industries, Inc.1988-05-03
7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM (K880776)Medsurg Industries, Inc.1988-05-02
INFANT CANNULA (K873012)Gresco International, Inc.1988-05-02
BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER (K874618)Bentley Laboratories, Inc.1988-01-19
TORAY ANTHRON ANGIOGRAPHIC CATHETERS (K872983)Toray Industries (America), Inc.1987-11-20
ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. (K870826)Shiley, Inc.1987-03-23
NEW MODEL STYLES FOR AORTIC ARCH CANNULA (K870825)Shiley, Inc.1987-03-23
SUBCLAVIAN JUGULAR CATHETER SET (K820102)Luther Medical Products, Inc.1982-01-29
INTRAFLON, INTRAFLUX, INTRAVALVE (K813144)Exco, Inc.1981-11-27
ELECATH FLUID-DRAIN ASSEMBLY (K803002)Electro-Catheter Corp.1980-12-22
CANNULA, ARTERY, RENAL (K780079)Dravon Medical, Inc.1978-02-13
CANNULA, INTRAVENOUS, R (K770512)Sherwood Medical Industries1977-03-30

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