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 |