Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Protrieve Sheath

K-Number: K230331 · 2023-03-07

Decision Date2023-03-07
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Protrieve Sheath is a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-03-07 under approval number K230331. 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 Protrieve Sheath?

Protrieve Sheath is a medical device that received FDA 510(k) clearance on 2023-03-07. It is manufactured by Inari Medical, Inc.. The 510(k) number is K230331.

When was Protrieve Sheath approved by the FDA?

Protrieve Sheath received FDA 510(k) clearance on 2023-03-07, under approval number K230331.

What company makes Protrieve Sheath?

Protrieve Sheath is manufactured by Inari Medical, Inc..

What is the FDA product code for Protrieve Sheath?

The FDA product code for Protrieve Sheath is QEW.

Related Clinical Trials

Other Devices by Inari Medical, Inc.

View all 29 devices →

Related Devices (Code: QEW)

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.