510(k) K140036
K140036 is an FDA 510(k) premarket notification submitted by Aptus Endosystems, Inc. for the device "APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH". The FDA issued a decision of Substantially Equivalent on February 6, 2014. The device falls under product code OTD (Endovascular Suturing System), a Class II device regulated under 21 CFR 870.3460. Aptus Endosystems, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2014
- Date Received
- January 7, 2014
- 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.