ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101
Device Facts
| Record ID | K010253 |
|---|---|
| Device Name | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 |
| Applicant | Transonic Systems, Inc. |
| Product Code | DYG · Cardiovascular |
| Decision Date | Mar 19, 2002 |
| 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.
