NDQClass II
System, Catheter Or Guidewire, Steerable (magnetic)
Cardiovascular · 21 CFR 870.1290
MDR events9All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances2All time
Recent MDR events
9 adverse event reports on file
- NIOBE MNS SIEMENSFeb 28, 2022InjuryStereotaxis3003084417-2021-00401
- NIOBE MNS PHILIPSSep 10, 2020MalfunctionStereotaxis3003084417-2020-00324
- NIOBE MNS PHILIPSJul 31, 2020MalfunctionStereotaxis3003084417-2020-00263
- NIOBE MNS PHILIPSJul 13, 2020MalfunctionStereotaxis3003084417-2020-00218
- GUIDEWIREApr 6, 2020InjurySt. Jude Medical, Inc.(crm-sylmar)2017865-2020-04661
- NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATIONSep 4, 2019InjuryStereotaxis, Inc3003084417-2018-00002
- SV-5 WIREJul 9, 2014MalfunctionCordis Corporation3937386
- ADAPTA DRApr 27, 2011Medtronic Adapta2087599
- NIOBE MAGNETIC NAVIGATION SYSTEMFeb 20, 2009MalfunctionStereotaxis, Inc.3003084417-2009-00001
Event type breakdown
Malfunction5
Injury3
Unspecified1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
2 clearances for this product code