The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Gyrus Acmi - Ezdilate 3-stage Balloon Dilatation Catheter.
| Device ID | K143609 |
| 510k Number | K143609 |
| Device Name: | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough, MA 01772 -2104 |
| Contact | Mary Anne Patella |
| Correspondent | Mary Anne Patella OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough, MA 01772 -2104 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-19 |
| Decision Date | 2015-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925033276 | K143609 | 000 |
| 00821925033269 | K143609 | 000 |
| 00821925033252 | K143609 | 000 |
| 00821925033245 | K143609 | 000 |
| 00821925033238 | K143609 | 000 |
| 00821925033221 | K143609 | 000 |