510(k) K182957
K182957 is an FDA 510(k) premarket notification submitted by Medtronic Vascular, Inc. for the device "Heli-FX EndoAnchor System". The FDA issued a decision of Substantially Equivalent on November 21, 2018. 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
- November 21, 2018
- Date Received
- October 24, 2018
- 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.