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FDA 510(k)

IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI

K-Number: K925827 · 1993-07-29

ApplicantImpra, Inc.
Decision Date1993-07-29
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1993-07-29 under 510(k) number K925827. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI?

IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI is a medical device that received FDA 510(k) clearance on 1993-07-29. The listed applicant is Impra, Inc.. The 510(k) number is K925827.

When did IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI receive FDA 510(k) clearance?

IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI received FDA 510(k) clearance on 1993-07-29, under 510(k) number K925827.

Who is the listed applicant for IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI?

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 IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI?

The FDA product code for IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI is CAC.

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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: CAC)

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.

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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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