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(ice) Catheter.
| Device ID | K212959 |
| 510k Number | K212959 |
| Device Name: | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98029 |
| Contact | Hyunjung Lee |
| Correspondent | Hyunjung Lee Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98029 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-16 |
| Decision Date | 2021-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869275079 | K212959 | 000 |