FlexCath Contour Steerable Sheath
Device Facts
| Record ID | K232321 |
|---|---|
| Device Name | FlexCath Contour Steerable Sheath |
| Applicant | Medtronic, Inc. |
| Product Code | DRA · Cardiovascular |
| Decision Date | Oct 31, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1280 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.
