The following data is part of a premarket notification filed by Mizuho America, Inc. with the FDA for Sugita Avm Microclip.
| Device ID | K960037 | 
| 510k Number | K960037 | 
| Device Name: | SUGITA AVM MICROCLIP | 
| Classification | Clip, Aneurysm | 
| Applicant | MIZUHO AMERICA, INC. 123 BRIMBAL AVE. Beverly, MA 01915 | 
| Contact | Lisa A Schweitzer | 
| Correspondent | Lisa A Schweitzer MIZUHO AMERICA, INC. 123 BRIMBAL AVE. Beverly, MA 01915 | 
| Product Code | HCH | 
| CFR Regulation Number | 882.5200 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1996-01-03 | 
| Decision Date | 1997-02-05 | 
| Summary: | summary |