510(k) DEN180021
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 1, 2019
- Date Received
- April 23, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intravascular Bleed Monitor
- Device Class
- Class II
- Regulation Number
- 870.1345
- Review Panel
- CV
- Submission Type
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.