Prelude Pursuit Splittable Sheath Introducer
K-Number: K172117 · 2017-09-11
ApplicantMerit Medical Systems, Inc.
Decision Date2017-09-11
Product CodeDYB
Advisory CommitteeCV
DecisionUnknown
Device Summary
Prelude Pursuit Splittable Sheath Introducer is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-09-11 under approval number K172117. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Unknown.
Frequently Asked Questions
What is the Prelude Pursuit Splittable Sheath Introducer?
Prelude Pursuit Splittable Sheath Introducer is a medical device that received FDA 510(k) clearance on 2017-09-11. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K172117.
When was Prelude Pursuit Splittable Sheath Introducer approved by the FDA?
Prelude Pursuit Splittable Sheath Introducer received FDA 510(k) clearance on 2017-09-11, under approval number K172117.
What company makes Prelude Pursuit Splittable Sheath Introducer?
Prelude Pursuit Splittable Sheath Introducer is manufactured by Merit Medical Systems, Inc..
What is the FDA product code for Prelude Pursuit Splittable Sheath Introducer?
The FDA product code for Prelude Pursuit Splittable Sheath Introducer is DYB.
Related Clinical Trials
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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.