Intravascular Bleed Monitor
The 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 in cardiovascular patients. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 870.1345 in the Cardiovascular specialty. The product code is QFJ. It is not an implant and is not life-sustaining.
Research product code QFJ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QFJ
- Device Class
- FDA class 2
- Regulation Number
- 870.1345
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.