BALLOON WEDGE PRESSURE CATHETER
Device Facts
| Record ID | K822034 |
|---|---|
| Device Name | BALLOON WEDGE PRESSURE CATHETER |
| Applicant | Ziehm International, Inc. |
| Product Code | DYG · Cardiovascular |
| Decision Date | Aug 24, 1982 |
| 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.
