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FDA 510(k)

FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815

K-Number: K100799 · 2011-02-25

ApplicantContract Medical Intl. GmbH
Decision Date2011-02-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 is the device name listed in this FDA 510(k) record. The listed applicant is Contract Medical Intl. GmbH. It received FDA 510(k) clearance on 2011-02-25 under 510(k) number K100799. 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 MODEL 358813, 358814, 358815?

FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 is a medical device that received FDA 510(k) clearance on 2011-02-25. The listed applicant is Contract Medical Intl. GmbH. The 510(k) number is K100799.

When did FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 receive FDA 510(k) clearance?

FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 received FDA 510(k) clearance on 2011-02-25, under 510(k) number K100799.

Who is the listed applicant for FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815?

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

What is the FDA product code for FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815?

The FDA product code for FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 is DYB.

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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

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

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