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FDA 510(k)

TETRAFLEX INTEGRALLY SUPPORTED PTFE

K-Number: K831822 · 1984-10-16

ApplicantShiley, Inc.
Decision Date1984-10-16
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TETRAFLEX INTEGRALLY SUPPORTED PTFE is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1984-10-16 under 510(k) number K831822. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TETRAFLEX INTEGRALLY SUPPORTED PTFE?

TETRAFLEX INTEGRALLY SUPPORTED PTFE is a medical device that received FDA 510(k) clearance on 1984-10-16. The listed applicant is Shiley, Inc.. The 510(k) number is K831822.

When did TETRAFLEX INTEGRALLY SUPPORTED PTFE receive FDA 510(k) clearance?

TETRAFLEX INTEGRALLY SUPPORTED PTFE received FDA 510(k) clearance on 1984-10-16, under 510(k) number K831822.

Who is the listed applicant for TETRAFLEX INTEGRALLY SUPPORTED PTFE?

The FDA 510(k) record lists Shiley, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TETRAFLEX INTEGRALLY SUPPORTED PTFE?

The FDA product code for TETRAFLEX INTEGRALLY SUPPORTED PTFE is DSY.

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Other records listing Shiley, Inc. as applicant

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Related Devices (Code: DSY)

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K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, 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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