Identifiers
- 510(k) Number
- K221914 FDA 510(k)
- FDA Product Code
- DYB 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)
The Catapult Guide Sheath is a catheter introducer device designed for peripheral endovascular procedures. It features an atraumatic tip with smooth transitions from sheath-dilator to dilator-wire, and a kink and crush-resistant shaft that provides excellent pushability.
The device is available in various tip configurations, French sizes, and lengths. It is a Class II medical device with product codes DYB and DRE, and has received FDA 510(k) clearance under regulation number 21 CFR 870.1340.
Frequently asked questions
What is the Catapult Guide Sheath used for?
The Catapult Guide Sheath is a catheter introducer device specifically designed for peripheral endovascular procedures. It features an atraumatic tip with smooth transitions and a kink-resistant shaft for excellent pushability during procedures.
What sizes and configurations are available for the Catapult Guide Sheath?
The Catapult Guide Sheath is available in various tip configurations, French sizes, and lengths to accommodate different clinical needs and procedural requirements. This variety allows clinicians to select the most appropriate option for specific cases.
What is the regulatory status of the Catapult Guide Sheath?
The Catapult Guide Sheath is a Class II medical device with product codes DYB and DRE. It has received FDA 510(k) clearance under regulation number 21 CFR 870.1340, with a decision date of July 29, 2022.
What are the key features of the Catapult Guide Sheath?
The device features an atraumatic tip with smooth transitions from sheath-dilator to dilator-wire, and a kink and crush-resistant shaft that provides excellent pushability. These features are designed to enhance performance and safety during peripheral endovascular procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Contract Medical International GmbH Jan Kubicek Lauensteiner Str. 37 ..., CATAPULT™ Guide Sheath - bostonscientific.com, K240957 - Catapult Guide Sheath | FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221914 | Class II | Active |
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Manufacturer
- Manufacturer
- Contract Medical International GmbH
- FDA Applicant
- Contract Medical International, GmbH
Sources (1)
- FDA 510(k) K221914 24 fields · synced Sep 26, 2026