FDA 510(k)

EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER

K-Number: K110103 · 2011-02-11

Decision Date2011-02-11

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2011-02-11 under 510(k) number K110103. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER?

EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER is a medical device that received FDA 510(k) clearance on 2011-02-11. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K110103.

When did EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER receive FDA 510(k) clearance?

EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER received FDA 510(k) clearance on 2011-02-11, under 510(k) number K110103.

Who is the listed applicant for EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER?

The FDA product code for EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER is DQO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.