FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED
Device Facts
| Record ID | K940547 |
|---|---|
| Device Name | FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED |
| Applicant | J-Lloyd Medical, Inc. |
| Product Code | DYG · Cardiovascular |
| Decision Date | Aug 11, 1994 |
| 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.
