Optical Coherence Tomography, Intravascular Catheter
Cardiovascular · 21 CFR 870.1200
For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.
Recent MDR events
41 adverse event reports on file
- DRAGONFLY OPSTAR¿Dec 14, 2021MalfunctionAbbott Vascular3009600098-2021-00028
- DRAGONFLY OPSTARMay 18, 2021MalfunctionAbbott Vascular3009600098-2021-00013
- DRAGONFLYMar 3, 2021InjuryAbbott Vascular3009600098-2021-00008
- DRAGONFLY OPSTARFeb 23, 2021InjuryAbbott Vascular3009600098-2021-00009
- DRAGONFLYSep 10, 2020InjurySt. Jude Medical Catd3009600098-2020-00021
- DRAGONFLYApr 16, 2020InjurySt. Jude Medical Catd3009600098-2020-00008
- DRAGONFLY¿ OPTIS¿ CATHETERSep 9, 2019InjurySt. Jude Medical Catd3009600098-2019-00021
- DRAGONFLY DUO IMAGING CATHETERAug 1, 2019MalfunctionSt. Jude Medical Catd3009600098-2019-00018
- DRAGONFLYJul 17, 2019InjurySt. Jude Medical Catd3009600098-2019-00017
- DRAGONFLY¿ OPTIS¿ CATHETERJun 6, 2019MalfunctionSt. Jude Medical Catd3009600098-2019-00012
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
11 firms currently registered for this product code
Sterigenics Eo Canada, Inc.
Mississauga Ontario, CA
Gentuity, Llc
Sudbury, MA, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Spectrawave, Inc.
Bedford, MA, US
Parter Medical Products, Inc.
CARSON, CA, US
Gentuity, Llc
Bedford, MA, US
Isomedix Operations Inc.
Northborough, MA, US
Isomedix Operations Inc.
WHIPPANY, NJ, US
Synergy Health Ast, Llc
Saxonburg, PA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.