510(k) K230273
K230273 is an FDA 510(k) premarket notification submitted by Saranas, Inc. for the device "Saranas Early Bird Bleed Monitoring System". The FDA issued a decision of Substantially Equivalent on May 25, 2023. The device falls under product code QFJ (Intravascular Bleed Monitor), a Class II device regulated under 21 CFR 870.1345. Saranas, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2023
- Date Received
- January 31, 2023
- Clearance Type
- Traditional
- 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.