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FDA 510(k)

GORE INTRODUCER SHEATH

K-Number: K013282 · 2001-12-14

ApplicantW. L. Gore & Associates, Inc.
Decision Date2001-12-14
Product CodeDBY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GORE INTRODUCER SHEATH 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 2001-12-14 under 510(k) number K013282. The device is classified under product code DBY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE INTRODUCER SHEATH?

GORE INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2001-12-14. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K013282.

When did GORE INTRODUCER SHEATH receive FDA 510(k) clearance?

GORE INTRODUCER SHEATH received FDA 510(k) clearance on 2001-12-14, under 510(k) number K013282.

Who is the listed applicant for GORE INTRODUCER SHEATH?

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?

The FDA product code for GORE INTRODUCER SHEATH is DBY.

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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: DBY)

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.

K022067CONVOY ADVANCED DELIVERY SHEATHBoston ScientificK013919TORFLEX TRANSSEPTAL GUIDING SHEATHBaylis Medical Co., Inc.K013304BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCERBecton Dickinson Infusion Therapy Systems, Inc.K013866CONVOY ADVANCED DELIVERY SHEATH KITBoston ScientificK771144RHODAMINE-CONJUGATED ANTISERUMKent Laboratories, Inc.

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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