The following data is part of a premarket notification filed by Aptus Endosystems, Inc. with the FDA for Aptus Heli-fx Aortic Securement System.
| Device ID | K130677 |
| 510k Number | K130677 |
| Device Name: | APTUS HELI-FX AORTIC SECUREMENT SYSTEM |
| Classification | Endovascular Suturing System |
| Applicant | APTUS ENDOSYSTEMS, INC. 271 GIBRALTAR DRIVE Sunnyvale, CA 94089 |
| Contact | Burt Goodson |
| Correspondent | Burt Goodson APTUS ENDOSYSTEMS, INC. 271 GIBRALTAR DRIVE Sunnyvale, CA 94089 |
| Product Code | OTD |
| CFR Regulation Number | 870.3460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-13 |
| Decision Date | 2013-04-12 |
| Summary: | summary |