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Intravascular Bleed Monitor

FDA product code QFJ · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1345
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-05-25 – 2023-05-25

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.

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