1 device · 1 company · 2023
Product code QFJ: Intravascular Bleed Monitor
1 device under product code QFJ, 2023, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Intravascular Bleed Monitor. 21 CFR 870.1345, Class II. 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. MAUDE held 3 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Saranas Early Bird Bleed Monitoring SystemK230273 · 510(k) | Saranas Inc. | Cardiovascular | database entry |
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