Decision Date2005-05-26
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
U-BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2005-05-26 under 510(k) number K050875. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the U-BALLOON DILATION CATHETER?
U-BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2005-05-26. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K050875.
When did U-BALLOON DILATION CATHETER receive FDA 510(k) clearance?
U-BALLOON DILATION CATHETER received FDA 510(k) clearance on 2005-05-26, under 510(k) number K050875.
Who is the listed applicant for U-BALLOON DILATION CATHETER?
The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for U-BALLOON DILATION CATHETER?
The FDA product code for U-BALLOON DILATION CATHETER is EZN.
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Official Source
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