Catapult Guide Sheath +28 more— 510(k) K250439

Clearance details

Device name as filed

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

Applicant

Contract Medical International, GmbH

Product code

Code DYB

Device class

Class 2

Regulation

21 CFR 870.1340

Advisory panel

Cardiovascular

Date received

2025-02-14

Decision date

2025-03-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Dresden, DE

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• K240957 — Catapult Guide Sheath2024-08-14
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• K203179 — Fortress Introducer Sheath System2020-11-20
• K181463 — DuraSheath Introducer Sheath System2018-12-13
• K153197 — Fortress Introducer Sheath SYstem2016-01-11

Death

808

Injury

5,922

Malfunction

16,516

Other

5

Total

23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →