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 |