Atlas FDA

HCD

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Cannula, Ventricular
Device class
Class I (low risk)
Regulation
21 CFR 882.4060
Medical specialty
Neurology
Adverse events (MAUDE)
1992: 1 · 1996: 1 · 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Alcyone MEMS Cannula (AMC) System (K150660)Alcyone Lifesciences, Inc.2015-04-16
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA (K102101)Surgivision, Inc.2011-01-26
CAMINO VENTRICULAR NEEDLE (K920088)Camino Laboratories, Inc.1992-05-01

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