MultiCath, AcQRate Dx Fixed Curve Catheter
K-Number: K201445 · 2021-09-02
ApplicantBiotronik, Inc.
Decision Date2021-09-02
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MultiCath, AcQRate Dx Fixed Curve Catheter is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2021-09-02 under approval number K201445. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MultiCath, AcQRate Dx Fixed Curve Catheter?
MultiCath, AcQRate Dx Fixed Curve Catheter is a medical device that received FDA 510(k) clearance on 2021-09-02. It is manufactured by Biotronik, Inc.. The 510(k) number is K201445.
When was MultiCath, AcQRate Dx Fixed Curve Catheter approved by the FDA?
MultiCath, AcQRate Dx Fixed Curve Catheter received FDA 510(k) clearance on 2021-09-02, under approval number K201445.
What company makes MultiCath, AcQRate Dx Fixed Curve Catheter?
MultiCath, AcQRate Dx Fixed Curve Catheter is manufactured by Biotronik, Inc..
What is the FDA product code for MultiCath, AcQRate Dx Fixed Curve Catheter?
The FDA product code for MultiCath, AcQRate Dx Fixed Curve Catheter is DRF.
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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.