True Flow Valvuloplasty Perfusion Catheter
K-Number: K152613 · 2016-01-19
ApplicantC.R. Bard, Inc.
Decision Date2016-01-19
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
True Flow Valvuloplasty Perfusion Catheter is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-01-19 under approval number K152613. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the True Flow Valvuloplasty Perfusion Catheter?
True Flow Valvuloplasty Perfusion Catheter is a medical device that received FDA 510(k) clearance on 2016-01-19. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K152613.
When was True Flow Valvuloplasty Perfusion Catheter approved by the FDA?
True Flow Valvuloplasty Perfusion Catheter received FDA 510(k) clearance on 2016-01-19, under approval number K152613.
What company makes True Flow Valvuloplasty Perfusion Catheter?
True Flow Valvuloplasty Perfusion Catheter is manufactured by C.R. Bard, Inc..
What is the FDA product code for True Flow Valvuloplasty Perfusion Catheter?
The FDA product code for True Flow Valvuloplasty Perfusion Catheter is OZT.
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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.