FieldFlex Steerable Sheath
Device Facts
| Record ID | K261492 |
|---|---|
| Device Name | FieldFlex Steerable Sheath |
| Applicant | CenterPoint Systems, LLC |
| Product Code | DYB · Cardiovascular |
| Decision Date | Jun 5, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
