Pounce(TM) Sheath
510(k) K252227
Pounce(TM) Sheath is a medical device (FDA Class II; FDA product code DYB, Introducer, Catheter) made by Surmodics, Inc., cleared under FDA 510(k) K252227 on 24 Sep 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252227 | Date24 Sep 2025 | StatusActive |
Official records
- FDA 510(k) database K252227
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DYB
- FDA applicant
- Surmodics,Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K252227
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Pounce Sheath PFS-0035-16F14 | PFS-0035-16F14 | 00812339030814 | — | On the market |
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