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FDA 510(k)

Fortress Introducer Sheath System

K-Number: K203179 · 2020-11-20

ApplicantContract Medical International, GmbH
Decision Date2020-11-20
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fortress Introducer Sheath System is a medical device manufactured by Contract Medical International, GmbH. It received FDA 510(k) clearance on 2020-11-20 under approval number K203179. 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 Fortress Introducer Sheath System?

Fortress Introducer Sheath System is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Contract Medical International, GmbH. The 510(k) number is K203179.

When was Fortress Introducer Sheath System approved by the FDA?

Fortress Introducer Sheath System received FDA 510(k) clearance on 2020-11-20, under approval number K203179.

What company makes Fortress Introducer Sheath System?

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

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

The FDA product code for Fortress 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 K181463DuraSheath 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

Related Devices (Code: DYB)

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC K162097InTRAkitMedtronic Vascular K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. K153771TXM Guiding SheathTexasmedical Technologies, Inc. K162184Edwards eSheath Introducer SetEdward Lifesciences K153494HQS Introducer (Model 2064-HQS)Alseal

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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