ClotTriever Sheath
K-Number: K233815 · 2023-12-18
ApplicantInari Medical, Inc.
Decision Date2023-12-18
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ClotTriever Sheath is a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-12-18 under approval number K233815. 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 ClotTriever Sheath?
ClotTriever Sheath is a medical device that received FDA 510(k) clearance on 2023-12-18. It is manufactured by Inari Medical, Inc.. The 510(k) number is K233815.
When was ClotTriever Sheath approved by the FDA?
ClotTriever Sheath received FDA 510(k) clearance on 2023-12-18, under approval number K233815.
What company makes ClotTriever Sheath?
ClotTriever Sheath is manufactured by Inari Medical, Inc..
What is the FDA product code for ClotTriever Sheath?
The FDA product code for ClotTriever Sheath is QEW.
Other Devices by Inari Medical, Inc.
Related Devices (Code: QEW)
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K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc.
K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical
K163549ClotTriever Thrombectomy SystemInari Medical, Inc.
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.