Decision Date1992-08-26
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
BARD STONE REMOVAL BALLOON 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 1992-08-26 under 510(k) number K920342. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BARD STONE REMOVAL BALLOON CATHETER?
BARD STONE REMOVAL BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1992-08-26. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K920342.
When did BARD STONE REMOVAL BALLOON CATHETER receive FDA 510(k) clearance?
BARD STONE REMOVAL BALLOON CATHETER received FDA 510(k) clearance on 1992-08-26, under 510(k) number K920342.
Who is the listed applicant for BARD STONE REMOVAL BALLOON 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 STONE REMOVAL BALLOON CATHETER?
The FDA product code for BARD STONE REMOVAL BALLOON CATHETER is GCA.
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Official Source
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