The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acunav 90/10 Diagnostic Ultrasound Catheter.
| Device ID | K033650 |
| 510k Number | K033650 |
| Device Name: | ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY Mountain View, CA 94039 -7393 |
| Contact | Iskra Mrakovic |
| Correspondent | Iskra Mrakovic SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY Mountain View, CA 94039 -7393 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-20 |
| Decision Date | 2004-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869001012 | K033650 | 000 |