510(k) K173031
K173031 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "AtriClip LAA Exclusion System with Preloaded PRO·V Clip". The FDA issued a decision of Substantially Equivalent on Oct 25, 2017. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. AtriCure, Inc. has 58 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 25, 2017
- Date Received
- Sep 28, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type
- 510(k)