Flextra Steerable Introducer
K-Number: K170373 · 2017-02-27
ApplicantRhythm Xience, Inc. (Rxi)
Decision Date2017-02-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Flextra Steerable Introducer is a medical device manufactured by Rhythm Xience, Inc. (Rxi). It received FDA 510(k) clearance on 2017-02-27 under approval number K170373. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Flextra Steerable Introducer?
Flextra Steerable Introducer is a medical device that received FDA 510(k) clearance on 2017-02-27. It is manufactured by Rhythm Xience, Inc. (Rxi). The 510(k) number is K170373.
When was Flextra Steerable Introducer approved by the FDA?
Flextra Steerable Introducer received FDA 510(k) clearance on 2017-02-27, under approval number K170373.
What company makes Flextra Steerable Introducer?
Flextra Steerable Introducer is manufactured by Rhythm Xience, Inc. (Rxi).
What is the FDA product code for Flextra Steerable Introducer?
The FDA product code for Flextra Steerable Introducer is DYB.
Related Clinical Trials
Other Devices by Rhythm Xience, Inc. (Rxi)
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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.