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FDA 510(k)

IMPRA HIGH POROSITY GRAFT

K-Number: K983064 · 1998-11-19

ApplicantImpra, Inc.
Decision Date1998-11-19
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPRA HIGH POROSITY 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 1998-11-19 under 510(k) number K983064. 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 IMPRA HIGH POROSITY GRAFT?

IMPRA HIGH POROSITY GRAFT is a medical device that received FDA 510(k) clearance on 1998-11-19. The listed applicant is Impra, Inc.. The 510(k) number is K983064.

When did IMPRA HIGH POROSITY GRAFT receive FDA 510(k) clearance?

IMPRA HIGH POROSITY GRAFT received FDA 510(k) clearance on 1998-11-19, under 510(k) number K983064.

Who is the listed applicant for IMPRA HIGH POROSITY 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 HIGH POROSITY GRAFT?

The FDA product code for IMPRA HIGH POROSITY 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 GRAFTK981076VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR 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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