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FDA 510(k)

GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

K-Number: K082356 · 2008-08-28

ApplicantW. L. Gore & Associates, Inc.
Decision Date2008-08-28
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2008-08-28 under 510(k) number K082356. 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 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE?

GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE is a medical device that received FDA 510(k) clearance on 2008-08-28. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K082356.

When did GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE receive FDA 510(k) clearance?

GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE received FDA 510(k) clearance on 2008-08-28, under 510(k) number K082356.

Who is the listed applicant for GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE?

The FDA product code for GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE is DYB.

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Other records listing W. L. Gore & Associates, Inc. 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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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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

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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