FDA.reportPublic FDA data

De Novo DEN100026

Device
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
Contact
burt goodson
De Novo number
DEN100026
Product code
OTD
Regulation
870.3460
Classification name
endovascular suturing system
Decision
granted (DENG)
Decision date
2011-11-21
Date received
2010-12-14
Classification advisory
Cardiovascular
Review advisory
Cardiovascular
Type
Post-NSE

Current FDA Classification#

Product code
OTD
Device name
Endovascular Suturing System
Medical specialty
Cardiovascular
Device class
2
Regulation
870.3460
Implant
Y
Life sustain/support
N