Dresden, DE · 4 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DYB | Introducer, Catheter | Class II | Cardiovascular | 4 | 2025-03-16 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-07-30 | Class II | Ongoing | Z-2532-2025 | Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 38… | — | Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rathe… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-03-16 | K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca | DYB | Class II | Cardiovascular |
| 2024-08-14 | K240957 | Catapult Guide Sheath | DYB | Class II | Cardiovascular |
| 2022-07-29 | K221914 | Catapult Guide Sheath | DYB | Class II | Cardiovascular |
| 2020-11-20 | K203179 | Fortress Introducer Sheath System | DYB | Class II | Cardiovascular |