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FDA 510(k)

Catapult Guide Sheath

K-Number: K221914 · 2022-07-29

ApplicantContract Medical International, GmbH
Decision Date2022-07-29
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Catapult Guide Sheath is a medical device manufactured by Contract Medical International, GmbH. It received FDA 510(k) clearance on 2022-07-29 under approval number K221914. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Catapult Guide Sheath?

Catapult Guide Sheath is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Contract Medical International, GmbH. The 510(k) number is K221914.

When was Catapult Guide Sheath approved by the FDA?

Catapult Guide Sheath received FDA 510(k) clearance on 2022-07-29, under approval number K221914.

What company makes Catapult Guide Sheath?

Catapult Guide Sheath is manufactured by Contract Medical International, GmbH.

What is the FDA product code for Catapult Guide Sheath?

The FDA product code for Catapult Guide Sheath is DYB.

Other Devices by Contract Medical International, GmbH

K153197Fortress Introducer Sheath SYstem K181463DuraSheath Introducer Sheath System K203179Fortress Introducer Sheath System K240957Catapult Guide Sheath K250439Catapult 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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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