FDA 510(k)

DIAGNOSTIC CATHETER SYSTEM

K-Number: K091250 · 2009-05-22

Decision Date2009-05-22

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Inc.. It received FDA 510(k) clearance on 2009-05-22 under 510(k) number K091250. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGNOSTIC CATHETER SYSTEM?

DIAGNOSTIC CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-22. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K091250.

When did DIAGNOSTIC CATHETER SYSTEM receive FDA 510(k) clearance?

DIAGNOSTIC CATHETER SYSTEM received FDA 510(k) clearance on 2009-05-22, under 510(k) number K091250.

Who is the listed applicant for DIAGNOSTIC CATHETER SYSTEM?

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

What is the FDA product code for DIAGNOSTIC CATHETER SYSTEM?

The FDA product code for DIAGNOSTIC CATHETER SYSTEM is EOQ.

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Related Devices (Code: EOQ)

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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.