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FDA 510(k)

PERIFUSE CATHETER

K-Number: K121525 · 2012-08-02

ApplicantSmiths Medical Asd, Inc.
Decision Date2012-08-02
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERIFUSE CATHETER 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 2012-08-02 under 510(k) number K121525. 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 PERIFUSE CATHETER?

PERIFUSE CATHETER is a medical device that received FDA 510(k) clearance on 2012-08-02. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K121525.

When did PERIFUSE CATHETER receive FDA 510(k) clearance?

PERIFUSE CATHETER received FDA 510(k) clearance on 2012-08-02, under 510(k) number K121525.

Who is the listed applicant for PERIFUSE CATHETER?

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 PERIFUSE CATHETER?

The FDA product code for PERIFUSE CATHETER is 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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