QFJ — Intravascular Bleed Monitor Class II
FDA product code QFJ covers "Intravascular Bleed Monitor", a Class II medical device regulated under 21 CFR 870.1345. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QFJ
- Device Class
- Class II
- Regulation Number
- 870.1345
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.