Steerable Introducer
K-Number: K191190 · 2019-08-01
ApplicantFreudenberg Medical, LLC
Decision Date2019-08-01
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Steerable Introducer is a medical device manufactured by Freudenberg Medical, LLC. It received FDA 510(k) clearance on 2019-08-01 under approval number K191190. 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 Steerable Introducer?
Steerable Introducer is a medical device that received FDA 510(k) clearance on 2019-08-01. It is manufactured by Freudenberg Medical, LLC. The 510(k) number is K191190.
When was Steerable Introducer approved by the FDA?
Steerable Introducer received FDA 510(k) clearance on 2019-08-01, under approval number K191190.
What company makes Steerable Introducer?
Steerable Introducer is manufactured by Freudenberg Medical, LLC.
What is the FDA product code for Steerable Introducer?
The FDA product code for Steerable Introducer is DYB.
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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.