FDA 510(k)

PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS

K-Number: K083451 · 2009-03-04

Decision Date2009-03-04

Product CodeBSN

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2009-03-04 under 510(k) number K083451. The device is classified under product code BSN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS?

PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS is a medical device that received FDA 510(k) clearance on 2009-03-04. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K083451.

When did PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS receive FDA 510(k) clearance?

PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS received FDA 510(k) clearance on 2009-03-04, under 510(k) number K083451.

Who is the listed applicant for PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS?

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

What is the FDA product code for PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS?

The FDA product code for PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS is BSN.

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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.