Pounce Thrombus Retrieval System
K-Number: K192814 · 2020-09-21
ApplicantSurmodics,Inc.
Decision Date2020-09-21
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Pounce Thrombus Retrieval System is a medical device manufactured by Surmodics,Inc.. It received FDA 510(k) clearance on 2020-09-21 under approval number K192814. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pounce Thrombus Retrieval System?
Pounce Thrombus Retrieval System is a medical device that received FDA 510(k) clearance on 2020-09-21. It is manufactured by Surmodics,Inc.. The 510(k) number is K192814.
When was Pounce Thrombus Retrieval System approved by the FDA?
Pounce Thrombus Retrieval System received FDA 510(k) clearance on 2020-09-21, under approval number K192814.
What company makes Pounce Thrombus Retrieval System?
Pounce Thrombus Retrieval System is manufactured by Surmodics,Inc..
What is the FDA product code for Pounce Thrombus Retrieval System?
The FDA product code for Pounce Thrombus Retrieval System is QEW.
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Official Source
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