The following data is part of a premarket notification filed by Aptus Endosystems with the FDA for Aptus Heli-fx Ancillary Endoanchor Cassette.
| Device ID | K141041 |
| 510k Number | K141041 |
| Device Name: | APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE |
| Classification | Endovascular Suturing System |
| Applicant | APTUS ENDOSYSTEMS 271 GIBRALTAR DR Sunnyvale, CA 94089 -0000 |
| Contact | Burt Goodson |
| Correspondent | Burt Goodson APTUS ENDOSYSTEMS 271 GIBRALTAR DR Sunnyvale, CA 94089 -0000 |
| Product Code | OTD |
| CFR Regulation Number | 870.3460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-23 |
| Decision Date | 2014-05-16 |
| Summary: | summary |