The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acunav Volume Ice Catheter.
| Device ID | K163478 |
| 510k Number | K163478 |
| Device Name: | AcuNav Volume ICE Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Shelly Pearce |
| Correspondent | Shelly Pearce 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 | 2016-12-12 |
| Decision Date | 2017-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869275079 | K163478 | 000 |