The following data is part of a premarket notification filed by Mizuho America, Inc. with the FDA for Sugita Avm Microclip Applier.
| Device ID | K221524 |
| 510k Number | K221524 |
| Device Name: | Sugita AVM Microclip Applier |
| Classification | Applier, Aneurysm Clip |
| Applicant | Mizuho America, Inc. 30057 Ahern Avenue Union City, CA 94587 |
| Contact | Richard Chadwick |
| Correspondent | Richard Chadwick Mizuho America, Inc. 30057 Ahern Avenue Union City, CA 94587 |
| Product Code | HCI |
| CFR Regulation Number | 882.4175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-26 |
| Decision Date | 2022-06-24 |