| K-number | K252227 |
| Device name | Pounce(TM) Sheath |
| Applicant | Surmodics,Inc. |
| Product code | DYB |
| Device class | Class II |
| Decision date | Sep 24, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
The Pounce™ Sheath is a catheter introducer intended to introduce therapeutic or diagnostic devices into the vasculature. It is used by clinical professionals to facilitate vascular access for diagnostic and therapeutic interventions.
Not stated in this summary.
Not stated.
The device is a catheter introducer regulated under 21 CFR 870.1340 that is substantially equivalent to legally marketed predicate devices. The device shares the same intended use and regulatory classification (Class II, product code DYB) as predicate introducers, with no new design features or materials identified that would raise additional safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov