510(k) K173711
K173711 is an FDA 510(k) premarket notification submitted by Wallaby Medical, Inc. for the device "Wallaby Avenir Coil System". The FDA issued a decision of Substantially Equivalent on May 4, 2018. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Wallaby Medical, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2018
- Date Received
- December 4, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Neurovascular Embolization
- Device Class
- Class II
- Regulation Number
- 882.5950
- Review Panel
- NE
- Submission Type