Decision Date1987-06-05
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
DORROS(TM) SMALL VESSEL PTA 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 1987-06-05 under 510(k) number K870460. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DORROS(TM) SMALL VESSEL PTA CATHETER?
DORROS(TM) SMALL VESSEL PTA CATHETER is a medical device that received FDA 510(k) clearance on 1987-06-05. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K870460.
When did DORROS(TM) SMALL VESSEL PTA CATHETER receive FDA 510(k) clearance?
DORROS(TM) SMALL VESSEL PTA CATHETER received FDA 510(k) clearance on 1987-06-05, under 510(k) number K870460.
Who is the listed applicant for DORROS(TM) SMALL VESSEL PTA 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 DORROS(TM) SMALL VESSEL PTA CATHETER?
The FDA product code for DORROS(TM) SMALL VESSEL PTA CATHETER is DXN.
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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.