K091352 is an FDA 510(k) clearance for the SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05. This device is classified as a Catheter, Ultrasound, Intravascular (Class II - Special Controls, product code OBJ).
Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on December 4, 2009, 211 days after receiving the submission on May 7, 2009.
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 | K091352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2009 |
| Decision Date | December 04, 2009 |
| Days to Decision | 211 days |
| Submission Type | Special |
| 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. |