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FDA 510(k)

EDWARDS DIRECTIONAL CATHETER

K-Number: K030630 · 2003-09-03

ApplicantEdwards Lifesciences, LLC
Decision Date2003-09-03
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDWARDS DIRECTIONAL 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 2003-09-03 under 510(k) number K030630. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDWARDS DIRECTIONAL CATHETER?

EDWARDS DIRECTIONAL CATHETER is a medical device that received FDA 510(k) clearance on 2003-09-03. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K030630.

When did EDWARDS DIRECTIONAL CATHETER receive FDA 510(k) clearance?

EDWARDS DIRECTIONAL CATHETER received FDA 510(k) clearance on 2003-09-03, under 510(k) number K030630.

Who is the listed applicant for EDWARDS DIRECTIONAL 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 DIRECTIONAL CATHETER?

The FDA product code for EDWARDS DIRECTIONAL CATHETER is DQY.

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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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