The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ultra Ice Plus – Pi 9 Mhz Peripheral Imaging Catheter.
| Device ID | K181042 |
| 510k Number | K181042 |
| Device Name: | Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter |
| Classification | Echocardiograph |
| Applicant | Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 |
| Contact | Jennifer L. Foley |
| Correspondent | Jennifer L. Foley Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-19 |
| Decision Date | 2018-05-17 |
| Summary: | summary |