Decision Date2000-01-31
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
BARD UROFORCE 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 2000-01-31 under 510(k) number K993840. 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 BARD UROFORCE BALLOON DILATION CATHETER?
BARD UROFORCE BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2000-01-31. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K993840.
When did BARD UROFORCE BALLOON DILATION CATHETER receive FDA 510(k) clearance?
BARD UROFORCE BALLOON DILATION CATHETER received FDA 510(k) clearance on 2000-01-31, under 510(k) number K993840.
Who is the listed applicant for BARD UROFORCE 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 BARD UROFORCE BALLOON DILATION CATHETER?
The FDA product code for BARD UROFORCE BALLOON DILATION CATHETER is EZN.
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Official Source
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