K071234 is an FDA 510(k) clearance for the ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F. 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 June 29, 2007, 57 days after receiving the submission on May 3, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200. For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology..
| 510(k) Number | K071234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2007 |
| Decision Date | June 29, 2007 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| 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. |