Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
Device Facts
| Record ID | K003118 |
|---|---|
| Device Name | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 |
| Applicant | Zcv ,Inc. |
| Product Code | DYG · Cardiovascular |
| Decision Date | Dec 20, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1240 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.
