510(k) K171427
K171427 is an FDA 510(k) premarket notification submitted by Medtronic Vascular, Inc. for the device "Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette". The FDA issued a decision of Substantially Equivalent on June 13, 2017. The device falls under product code OTD (Endovascular Suturing System), a Class II device regulated under 21 CFR 870.3460. Medtronic Vascular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2017
- Date Received
- May 15, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endovascular Suturing System
- Device Class
- Class II
- Regulation Number
- 870.3460
- Review Panel
- CV
- Submission Type
Provides fixation and sealing between and endovascular graft and the native artery.