K240050 is an FDA 510(k) clearance for the SOUNDSTAR™ CRYSTAL Ultrasound Catheter. This device is classified as a Catheter, Ultrasound, Intravascular (Class II - Special Controls, product code OBJ).
Submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on June 12, 2024, 156 days after receiving the submission on January 8, 2024.
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 | K240050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2024 |
| Decision Date | June 12, 2024 |
| Days to Decision | 156 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. |