The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmi – Ezdilate 3-stage Balloon Dilatation Catheter.
| Device ID | K180086 |
| 510k Number | K180086 |
| Device Name: | Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772 |
| Contact | Mary Anne Patella |
| Correspondent | Mary Anne Patella Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-12 |
| Decision Date | 2018-03-08 |
| Summary: | summary |