DEN180021 is an FDA 510(k) submission for the 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 Not Cleared (DENG) decision on March 1, 2019.
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 | DEN180021 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 23, 2018 |
| Decision Date | March 01, 2019 |
| Days to Decision | 312 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| 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. |