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