FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
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
K Number: K250439
·
Decision Mar 16, 2025
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
7
Review Days
30
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Basic Information
- Device Name
- 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
- K Number
- K250439
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Contract Medical International, GmbH
- Date Received
- February 14, 2025
- Decision Date
- March 16, 2025
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Contract Medical International, GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K240957 | Catapult Guide Sheath | Aug 14, 2024 | Substantially Equivalent |
| K221914 | Catapult Guide Sheath | Jul 29, 2022 | Substantially Equivalent |
| K203179 | Fortress Introducer Sheath System | Nov 20, 2020 | Substantially Equivalent |
| K181463 | DuraSheath Introducer Sheath System | Dec 13, 2018 | Substantially Equivalent |
| K153197 | Fortress Introducer Sheath SYstem | Jan 11, 2016 | Substantially Equivalent |
| K142357 | DuraSheath Introducer Sheath System | Jun 25, 2015 | Substantially Equivalent |