K033650 is an FDA 510(k) clearance for the ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER. This device is classified as a Catheter, Ultrasound, Intravascular (Class II - Special Controls, product code OBJ).
Submitted by Siemens Medical Solutions USA, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 24, 2004, 96 days after receiving the submission on November 20, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.1200. For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology..
| 510(k) Number | K033650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2003 |
| Decision Date | February 24, 2004 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OBJ — Catheter, Ultrasound, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology. |