MEDTRONIC S3 TM SYSTEM
Device Facts
| Record ID | K821004 |
|---|---|
| Device Name | MEDTRONIC S3 TM SYSTEM |
| Applicant | Medtronic Vascular |
| Product Code | DYG · Cardiovascular |
| Decision Date | May 25, 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.
