510(k) K173323
K173323 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "AnastoClip GC Closure System". The FDA issued a decision of Substantially Equivalent on March 8, 2018. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2018
- Date Received
- October 20, 2017
- Clearance Type
- Traditional
- 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