The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ultra Ice Plus 9 Mhz Intracardiac Echo Catheter(edfu), Ultra Ice Plus 9 Mhz Intracardiac Echo Catheter (paper Dfu).
| Device ID | K160173 |
| 510k Number | K160173 |
| Device Name: | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) |
| Classification | Echocardiograph |
| Applicant | Boston Scientific Corporation 47215 Lakeview Boulevard Fremont, CA 94538 |
| Contact | Eric Elliott |
| Correspondent | Eric Elliott Boston Scientific Corporation 47215 Lakeview Boulevard Fremont, CA 94538 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-02-26 |
| Summary: | summary |