The following data is part of a De Novo classification by Aptus Endosystems, Inc. with the FDA for Aptus Steerable Endoguide With Obturator, Aptus Endostaple Applier With Endostaple Cassette, Aptus Endostaple Cassette.
DeNovo ID | DEN100026 |
Device Name: | APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE |
Classification | Endovascular Suturing System |
Applicant | APTUS ENDOSYSTEMS, INC. 777 N. Pastoria Ave. Sunnyvale, CA 94085 |
Contact | Burt Goodson |
Product Code | OTD |
CFR Regulation Number | 870.3460 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | K102333 |
Review Advisory Board | Cardiovascular |
Classification Advisory | Cardiovascular |
Type | Post-NSE |
Date Received | 2010-12-14 |
Decision Date | 2011-11-21 |
FDA Review | Decision Summary |
Reclassification Order: | Reclassification Order |