Pounce™ Sheath
510(k) K231828
Pounce Sheath is a medical device (FDA Class II; FDA product code DYB, Introducer, Catheter) made by Surmodics, Inc., cleared under FDA 510(k) K231828 on 7 Sep 2023, active as of 25 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 | NumberK231828 | Date7 Sep 2023 | StatusActive |
Official records
- FDA 510(k) database K231828
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- Withdrawn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 K231828
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-0035-12F14 | PFS-0035-12F14 | 00812339030753 | — | On the market |
Similar devices
Other devices filed under FDA product code DYB (Introducer, Catheter).
- INTRODUCER, CAT. #INT-07FR. by Sorensen Research
- CANNULA INTRODUCER by Cardiovascular Research, Inc.
- Occlutech Delivery Set III 98DL009 by Oscor Inc.
- DUAL GUIDE INTRODUCER CATHETER by Cook, Inc.
- MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 by Cryocor, Inc.
- CORDIS AVANTI CATHETER SHEATH INTRODUCER by Cordis US Corp.
- PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH by TERUMO MEDICAL CORPORATION
- USCI(R) ACCESS(TM) INTRODUCER SET by C. R. Bard, Inc.
- Prelude Guide Sheath by Merit Medical Systems, Inc.
- Adelante Breezeway AB063001 by Oscor Inc.