K242608 is an FDA 510(k) clearance for the Embozene Color-Advanced Microspheres. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on January 17, 2025, 136 days after receiving the submission on September 3, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K242608 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2024 |
| Decision Date | January 17, 2025 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KRD — Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |