The following data is part of a premarket notification filed by Vesocclude Medical, Llc with the FDA for Vesocclude Polymer Ligating Clip.
Device ID | K152082 |
510k Number | K152082 |
Device Name: | Vesocclude Polymer Ligating Clip |
Classification | Clip, Implantable |
Applicant | Vesocclude Medical, LLC 7429 ACC BLVD Suite 101 Raleigh, NC 27617 |
Contact | Freddy Cannady |
Correspondent | Freddy Cannady Vesocclude Medical, LLC 7429 ACC BLVD Suite 101 Raleigh, NC 27617 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-27 |
Decision Date | 2016-02-26 |
Summary: | summary |