Endovascular Suturing System
The Endovascular Suturing System (product code OTD) is a cardiovascular device that provides fixation and sealing between an endovascular graft and the native artery. It is used during endovascular repair of aortic aneurysms or other vascular conditions to secure the proximal and distal ends of the graft and prevent endoleaks. As an FDA Class 2 device under regulation 870.3460, it requires 510(k) premarket clearance and falls within the Cardiovascular specialty. The device is flagged as an implant and is not life-sustaining.
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Basic Information
- Product Code
- OTD
- Device Class
- FDA class 2
- Regulation Number
- 870.3460
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Provides fixation and sealing between and endovascular graft and the native artery.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K182957 | Heli-FX EndoAnchor System | Nov 21, 2018 | Substantially Equivalent | Medtronic Vascular, Inc. |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | Jun 13, 2017 | Substantially Equivalent | Medtronic Vascular, Inc. |
| K141041 | APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE | May 16, 2014 | Substantially Equivalent | Aptus Endosystems |
| K140036 | APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH | Feb 06, 2014 | Substantially Equivalent | Aptus Endosystems, Inc. |
| K130677 | APTUS HELI-FX AORTIC SECUREMENT SYSTEM | Apr 12, 2013 | Substantially Equivalent | Aptus Endosystems, Inc. |
| K121168 | APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH | Aug 08, 2012 | Substantially Equivalent | Aptus Endosystems, Inc. |
| DEN100026 | APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE | Nov 21, 2011 | Unknown | Aptus Endosystems, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.