510(k) K140036
- Device
- APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH
- Applicant
- APTUS ENDOSYSTEMS, INC.
- 510(k) number
- K140036
- Product code
- OTD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-02-06
- Date received
- 2014-01-07
- Regulation
- 870.3460
- Classification name
- Endovascular Suturing System
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BURT GOODSON
- Address
- 271 Gibraltar Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 9612164
- 3002807314
- 2953200
- 3009380063
- 2011171
Source Documents#
Other 510(k) Records For Product Code OTD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182957 | Heli-FX EndoAnchor System | Medtronic Vascular, Inc. | 2018-11-21 |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | Medtronic Vascular, Inc. | 2017-06-13 |
| K141041 | APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE | Aptus Endosystems | 2014-05-16 |
| K130677 | APTUS HELI-FX AORTIC SECUREMENT SYSTEM | Aptus Endosystems, Inc. | 2013-04-12 |
| K121168 | APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH | Aptus Endosystems, Inc. | 2012-08-08 |
| DEN100026 | APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE | Aptus Endosystems, Inc. | 2011-11-21 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases