Definition: The Adjunctive Predictive Cardiovascular Indicator Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict Future Cardiovascular Status Or Events. This Device Is Intended For Adjunctive Use With Other
| Device Type ID | 989 |
| Device Name | Adjunctive Predictive Cardiovascular Indicator |
| Physical State | The Device Consists Of Software Shipped On A Patient Monitor. It Collects Data From First- Or Third-party Sensors Attached To The Patient. |
| Technical Method | The Device Combines Data Collected From Indwelling Catheters To Produce A Single Value That Estimates The Likelihood Of A Future Adverse Cardiovascular Event. |
| Target Area | The Device Target Area Is Systemic Due To The Broad Effects Of Hypotension During Surgical Procedures. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2210 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 989 |
| Device | Adjunctive Predictive Cardiovascular Indicator |
| Product Code | QAQ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 870.2210 [🔎] |
| Premarket Reviews | ||
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| Manufacturer | Decision | |
EDWARDS LIFESCIENCES | ||
GRANTED | 1 | |
EDWARDS LIFESCIENCES LLC | ||
GRANTED | 1 | |