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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 the device name listed in this FDA 510(k) record. The listed applicant is Contract Medical International, GmbH. It received FDA 510(k) clearance on 2020-11-20 under 510(k) 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. The listed applicant is Contract Medical International, GmbH. The 510(k) number is K203179.

When did Fortress Introducer Sheath System receive FDA 510(k) clearance?

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

Who is the listed applicant for Fortress Introducer Sheath System?

The FDA 510(k) record lists Contract Medical International, GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Contract Medical International, GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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); CaK240957Catapult Guide SheathK221914Catapult Guide SheathK181463DuraSheath Introducer Sheath SystemK153197Fortress Introducer Sheath SYstem

Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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