K230273 is an FDA 510(k) clearance for the Saranas Early Bird Bleed Monitoring System. This device is classified as a Intravascular Bleed Monitor (Class II - Special Controls, product code QFJ).
Submitted by Saranas, Inc. (Houston, US). The FDA issued a Cleared decision on May 25, 2023, 114 days after receiving the submission on January 31, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1345. An Intravascular Bleed Monitor Is A Probe, Catheter, Or Catheter Introducer That Measures Changes In Bioimpedance And Uses An Algorithm To Detect Or Monitor Progression Of Potential Internal Bleeding Complications..
| 510(k) Number | K230273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2023 |
| Decision Date | May 25, 2023 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QFJ - Intravascular Bleed Monitor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1345 |
| Definition | An Intravascular Bleed Monitor Is A Probe, Catheter, Or Catheter Introducer That Measures Changes In Bioimpedance And Uses An Algorithm To Detect Or Monitor Progression Of Potential Internal Bleeding Complications. |