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FDA 510(k)

DuraSheath Introducer Sheath System

K-Number: K181463 · 2018-12-13

ApplicantContract Medical International, GmbH
Decision Date2018-12-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DuraSheath Introducer Sheath System is a medical device manufactured by Contract Medical International, GmbH. It received FDA 510(k) clearance on 2018-12-13 under approval number K181463. 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 DuraSheath Introducer Sheath System?

DuraSheath Introducer Sheath System is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by Contract Medical International, GmbH. The 510(k) number is K181463.

When was DuraSheath Introducer Sheath System approved by the FDA?

DuraSheath Introducer Sheath System received FDA 510(k) clearance on 2018-12-13, under approval number K181463.

What company makes DuraSheath Introducer Sheath System?

DuraSheath Introducer Sheath System is manufactured by Contract Medical International, GmbH.

What is the FDA product code for DuraSheath Introducer Sheath System?

The FDA product code for DuraSheath Introducer Sheath System is DYB.

Related Clinical Trials

NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06223789 VOLT-AF IDE Clinical Study COMPLETED

Other Devices by Contract Medical International, GmbH

K153197Fortress Introducer Sheath SYstem K203179Fortress Introducer Sheath System K221914Catapult Guide Sheath 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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