The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson Acunav Volume Intracardiac Echocardiography Catheter.
| Device ID | K173618 |
| 510k Number | K173618 |
| Device Name: | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Hyunjung Lee |
| Correspondent | Hyunjung Lee Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-22 |
| Decision Date | 2017-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869004266 | K173618 | 000 |