QFJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intravascular Bleed Monitor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1345
- Medical specialty
- Cardiovascular
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Saranas Early Bird Bleed Monitoring System (K230273) | Saranas, Inc. | 2023-05-25 | + Add |
| Early Bird Bleed Monitoring System (DEN180021) | Saranas, Inc. | 2019-03-01 |
Track QFJ automatically
Every clearance here is in the API, with alerts when new ones post.