The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Anastoclip Gc Closure System.
Device ID | K173323 |
510k Number | K173323 |
Device Name: | AnastoClip GC Closure System |
Classification | Clip, Implantable |
Applicant | LeMaitre Vascular, Inc. 63 Second Ave. Burlington, MA 01803 |
Contact | Xiang Zhang |
Correspondent | Xiang Zhang LeMaitre Vascular, Inc. 63 Second Ave. Burlington, MA 01803 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-20 |
Decision Date | 2018-03-08 |
Summary: | summary |