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FDA 510(k)

VASCULAR GRAFT PROST. OF EXPANDED PTFE

K-Number: K791810 · 1979-10-09

ApplicantImpra, Inc.
Decision Date1979-10-09
Product CodeDYF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCULAR GRAFT PROST. OF EXPANDED PTFE is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1979-10-09 under 510(k) number K791810. The device is classified under product code DYF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAR GRAFT PROST. OF EXPANDED PTFE?

VASCULAR GRAFT PROST. OF EXPANDED PTFE is a medical device that received FDA 510(k) clearance on 1979-10-09. The listed applicant is Impra, Inc.. The 510(k) number is K791810.

When did VASCULAR GRAFT PROST. OF EXPANDED PTFE receive FDA 510(k) clearance?

VASCULAR GRAFT PROST. OF EXPANDED PTFE received FDA 510(k) clearance on 1979-10-09, under 510(k) number K791810.

Who is the listed applicant for VASCULAR GRAFT PROST. OF EXPANDED PTFE?

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 VASCULAR GRAFT PROST. OF EXPANDED PTFE?

The FDA product code for VASCULAR GRAFT PROST. OF EXPANDED PTFE is DYF.

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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: DYF)

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 GRAFTSImpra, Inc.K000504ADVANTA SUPER SOFT GRAFTAtrium Medical Corp.K992958ADVANTA GRAFT (<6MM)Atrium Medical Corp.K991683PTFE RINGED GORE-TEX VASCULAR GRAFTW. L. Gore & Associates, Inc.K992441ADVANTA GRAFTAtrium Medical Corp.K984183PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451Possis Medical, 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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