Atlas FDA

NDQ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
System, Catheter Or Guidewire, Steerable (Magnetic)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1290
Medical specialty
Cardiovascular
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RecordFirmDate
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION (K060967)Stereotaxis, Inc.2006-10-19
CRONUS GUIDEWIRE, MODEL 001-001470-1 (K051373)Stereotaxis, Inc.2005-12-09

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