COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
Device Facts
| Record ID | K103715 |
|---|---|
| Device Name | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE |
| Applicant | Mirador Biomedical, Inc. |
| Product Code | DRS · Cardiovascular |
| Decision Date | Jan 20, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.2850 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.