K223905 is an FDA 510(k) clearance for the Vivio® LVEDP System. This device is classified as a Adjunctive Heart Failure Status Indicator (Class II - Special Controls, product code QUO).
Submitted by Avicena, LLC (Pasadena, US). The FDA issued a Cleared decision on October 6, 2023, 282 days after receiving the submission on December 28, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2200. The Adjunctive Heart Failure Status Indicator Is A Prescription Device Based On Sensor Technology Or Image Data To Provide Information To An Interpreting Clinician In Detecting Heart Failure. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy..
| 510(k) Number | K223905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2022 |
| Decision Date | October 06, 2023 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QUO - Adjunctive Heart Failure Status Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2200 |
| Definition | The Adjunctive Heart Failure Status Indicator Is A Prescription Device Based On Sensor Technology Or Image Data To Provide Information To An Interpreting Clinician In Detecting Heart Failure. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy. |