Heli-FX EndoAnchor System
FDA 510(k) K182957 · Medtronic Vascular, Inc.
510(k) numberK182957
Submission
- Device name
- Heli-FX EndoAnchor System
- Applicant
- Medtronic Vascular, Inc.
Santa Rosa, CA, US - Received
- October 24, 2018
- Decision date
- November 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OTD – Endovascular Suturing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3460
- Specialty
- Cardiovascular
- Implant
- Yes
Provides fixation and sealing between and endovascular graft and the native artery.
Other 510(k)s with product code OTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD · Special | Medtronic Vascular, Inc. | 06/13/2017SE |
| K141041 | Aptus Heli-Fx Ancillary Endoanchor CassetteOTD · Special | Aptus Endosystems | 05/16/2014SE |
| K140036 | Aptus Heli-Fx Guide - 22CM Deflectable Length; Aptus Heli-Fx Guide - 28CM Deflectable…OTD · Special | Aptus Endosystems, Inc. | 02/06/2014SE |
| K130677 | Aptus Heli-Fx Aortic Securement SystemOTD · Special | Aptus Endosystems, Inc. | 04/12/2013SE |
| K121168 | Aptus 18FR Helifx GUIDE-22 Deflectable LengthOTD · Traditional | Aptus Endosystems, Inc. | 08/08/2012SE |
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| K173515 | Admiral XtremeLIT · Traditional | 04/12/2018SE |
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| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCW · Special | 06/16/2017SE |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD · Special | 06/13/2017SE |
| K162097 | InTRAkitDYB · Traditional | 11/17/2016SE |
Questions and answers
When was Heli-FX EndoAnchor System cleared by the FDA?
Heli-FX EndoAnchor System (K182957) received a 510(k) decision of Substantially Equivalent on November 21, 2018, 28 days after the submission was received.
What is the product code of K182957?
The FDA product code is OTD – Endovascular Suturing System, a Class II (moderate risk) device regulated under 21 CFR 870.3460.