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FDA 510(k)

DIRECTVISION CATHETER, UNCOATED

K-Number: K110214 · 2011-05-27

ApplicantPercuvision
Decision Date2011-05-27
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIRECTVISION CATHETER, UNCOATED is the device name listed in this FDA 510(k) record. The listed applicant is Percuvision. It received FDA 510(k) clearance on 2011-05-27 under 510(k) number K110214. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECTVISION CATHETER, UNCOATED?

DIRECTVISION CATHETER, UNCOATED is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Percuvision. The 510(k) number is K110214.

When did DIRECTVISION CATHETER, UNCOATED receive FDA 510(k) clearance?

DIRECTVISION CATHETER, UNCOATED received FDA 510(k) clearance on 2011-05-27, under 510(k) number K110214.

Who is the listed applicant for DIRECTVISION CATHETER, UNCOATED?

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

What is the FDA product code for DIRECTVISION CATHETER, UNCOATED?

The FDA product code for DIRECTVISION CATHETER, UNCOATED is EZL.

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Official Source

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