Identifiers
- 510(k) Number
- K250439 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
- Models / Variants
- Catapult Guide Sheath FDA 510(k)4F FDA 510(k)15cm (US-34015-F-ST-H) FDA 510(k)Catapult Guide Sheath FDA 510(k)4F FDA 510(k)45cm (US-34045-F-ST-H) FDA 510(k)Catapult Guide Sheath FDA 510(k)4F FDA 510(k)60cm (US-34060-F-ST-H) FDA 510(k)Catapult Guide Sheath FDA 510(k)4F FDA 510(k)90cm (US-34090-F-ST-H) FDA 510(k)Catapult Guide Sheath FDA 510(k)4F FDA 510(k)130cm (US-34130-F-ST-H) FDA 510(k)Catapult Guide Sheath FDA 510(k)5F FDA 510(k)15cm (US-35015-F-ST-H) FDA 510(k)Catapult Guide Sheath FDA 510(k)5F FDA 510(k)45cm (US-35045-F-ST-H) FDA 510(k)Catapult Guide Sheath FDA 510(k)5F FDA 510(k)45cm FDA 510(k)Hockey Stick (US-35045-F-HS-H) FDA 510(k)Catapult Guide Sheath FDA 510(k)5F FDA 510(k)45cm FDA 510(k)Multipurpose (US-35045-F-MP-H) FDA 510(k)Ca FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Catapult Guide Sheath - 4F by Contract Medical International GmbH — Class II — FDA_510K — listed in FDA 510(k) — 30 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250439 | Class II | Active |
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Manufacturer
- Manufacturer
- Contract Medical International GmbH
- FDA Applicant
- Contract Medical International, GmbH
Sources (1)
- FDA 510(k) K250439 24 fields · synced Jun 18, 2026