FDA 510(k)

ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400

K-Number: K023630 · 2003-02-20

ApplicantGuidant Corporation, Cardiac Surgery

Decision Date2003-02-20

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corporation, Cardiac Surgery. It received FDA 510(k) clearance on 2003-02-20 under 510(k) number K023630. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400?

ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 is a medical device that received FDA 510(k) clearance on 2003-02-20. The listed applicant is Guidant Corporation, Cardiac Surgery. The 510(k) number is K023630.

When did ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 receive FDA 510(k) clearance?

ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 received FDA 510(k) clearance on 2003-02-20, under 510(k) number K023630.

Who is the listed applicant for ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400?

The FDA 510(k) record lists Guidant Corporation, Cardiac Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400?

The FDA product code for ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 is GCJ.

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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.