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FDA 510(k)

IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT

K-Number: K971192 · 1997-04-15

ApplicantImpra, Inc.
Decision Date1997-04-15
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1997-04-15 under 510(k) number K971192. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT?

IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT is a medical device that received FDA 510(k) clearance on 1997-04-15. The listed applicant is Impra, Inc.. The 510(k) number is K971192.

When did IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT receive FDA 510(k) clearance?

IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT received FDA 510(k) clearance on 1997-04-15, under 510(k) number K971192.

Who is the listed applicant for IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT?

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

What is the FDA product code for IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT?

The FDA product code for IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT is DSY.

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Other records listing Impra, 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.

K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTSK004011IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESSK991027BI-DIRECTIONAL TUNNELERK983769DISTAFLO BYPASS GRAFTK983861DISTAFLO BYPASS GRAFTK983064IMPRA HIGH POROSITY GRAFT

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Related Devices (Code: DSY)

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.

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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