Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
K-Number: K153430 · 2016-03-07
ApplicantCook Incorporated
Decision Date2016-03-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-03-07 under approval number K153430. 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 Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select?
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select is a medical device that received FDA 510(k) clearance on 2016-03-07. It is manufactured by Cook Incorporated. The 510(k) number is K153430.
When was Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select approved by the FDA?
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select received FDA 510(k) clearance on 2016-03-07, under approval number K153430.
What company makes Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select?
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select is manufactured by Cook Incorporated.
What is the FDA product code for Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select?
The FDA product code for Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select 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.