Intravascular Bleed Monitor
Device Code: 997
Product Code(s):
QFJ 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.
Device Classification Information
Device Type ID | 997 |
Device Name | Intravascular Bleed Monitor |
Physical State | Catheter Introducer With Embedded Electrodes |
Technical Method | The Device Measures Changes In Bioimpedance And Uses An Algorithm To Monitor Progression Of Internal Bleeding Complications |
Target Area | Vasculature |
Regulation Medical Specialty | Cardiovascular |
Review Panel | Cardiovascular |
Submission Type | 510(k) |
CFR Regulation Number | 870.1345 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | QFJ |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
Device Type ID | 997 |
Device | Intravascular Bleed Monitor |
Product Code | QFJ |
FDA Device Classification | Class 2 Medical Device |
CFR Regulation Number | 870.1345 [🔎] |
TPLC Last Update: 2019-04-02 18:23:18