The following data is part of a premarket notification filed by A2 Medical Systems, Llc with the FDA for Angiolock Polymer Ligating Clip.
Device ID | K220006 |
510k Number | K220006 |
Device Name: | AngioLOCK Polymer Ligating Clip |
Classification | Clip, Implantable |
Applicant | A2 Medical Systems, LLC 6387 Technology Ave. Kalamazoo, MI 49009 |
Contact | Robert Hall |
Correspondent | Robert Hall A2 Medical Systems, LLC 6387 Technology Ave. Kalamazoo, MI 49009 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-04 |
Decision Date | 2022-03-02 |