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FDA 510(k)

EPIFUSE CATHETER CONNECTOR, MODEL: 4909E

K-Number: K092657 · 2009-11-04

ApplicantSmiths Medical Asd, Inc.
Decision Date2009-11-04
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EPIFUSE CATHETER CONNECTOR, MODEL: 4909E 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 2009-11-04 under 510(k) number K092657. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIFUSE CATHETER CONNECTOR, MODEL: 4909E?

EPIFUSE CATHETER CONNECTOR, MODEL: 4909E is a medical device that received FDA 510(k) clearance on 2009-11-04. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K092657.

When did EPIFUSE CATHETER CONNECTOR, MODEL: 4909E receive FDA 510(k) clearance?

EPIFUSE CATHETER CONNECTOR, MODEL: 4909E received FDA 510(k) clearance on 2009-11-04, under 510(k) number K092657.

Who is the listed applicant for EPIFUSE CATHETER CONNECTOR, MODEL: 4909E?

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 EPIFUSE CATHETER CONNECTOR, MODEL: 4909E?

The FDA product code for EPIFUSE CATHETER CONNECTOR, MODEL: 4909E is CAZ.

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Related Devices (Code: CAZ)

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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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