Device Classification Name |
endovascular suturing system
|
De Novo Number |
DEN100026 |
510(K) Number |
K102333
|
Device Name |
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE |
Requester |
aptus endosystems, inc. |
777 n. pastoria ave. |
sunnyvale,
CA
94085
|
|
Contact |
burt goodson |
|
Regulation Number | 870.3460
|
Classification Product Code |
|
Date Received | 12/14/2010 |
Decision Date | 11/21/2011 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|