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FDA 510(k)

DISTAFLO BYPASS GRAFT

K-Number: K983769 · 1998-12-15

ApplicantImpra, Inc.
Decision Date1998-12-15
Product CodeDYF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISTAFLO BYPASS 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 1998-12-15 under 510(k) number K983769. 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 DISTAFLO BYPASS GRAFT?

DISTAFLO BYPASS GRAFT is a medical device that received FDA 510(k) clearance on 1998-12-15. The listed applicant is Impra, Inc.. The 510(k) number is K983769.

When did DISTAFLO BYPASS GRAFT receive FDA 510(k) clearance?

DISTAFLO BYPASS GRAFT received FDA 510(k) clearance on 1998-12-15, under 510(k) number K983769.

Who is the listed applicant for DISTAFLO BYPASS 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 DISTAFLO BYPASS GRAFT?

The FDA product code for DISTAFLO BYPASS GRAFT 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 TUNNELERK983861DISTAFLO BYPASS GRAFTK983064IMPRA HIGH POROSITY GRAFTK981076VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT

View all 29 devices →

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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