FDA 510(k)

REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER

K-Number: K121913 · 2012-12-20

ApplicantStryker Sustainability Solutions, Inc.

Decision Date2012-12-20

Product CodeOWQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions, Inc.. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K121913. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER?

REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Stryker Sustainability Solutions, Inc.. The 510(k) number is K121913.

When did REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER receive FDA 510(k) clearance?

REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER received FDA 510(k) clearance on 2012-12-20, under 510(k) number K121913.

Who is the listed applicant for REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER?

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

What is the FDA product code for REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER?

The FDA product code for REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER is OWQ.

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Official Source

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