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)

Triever16 Curve

K-Number: K223419 · 2023-03-23

ApplicantInari Medical
Decision Date2023-03-23
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Triever16 Curve is a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2023-03-23 under approval number K223419. 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 Triever16 Curve?

Triever16 Curve is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by Inari Medical. The 510(k) number is K223419.

When was Triever16 Curve approved by the FDA?

Triever16 Curve received FDA 510(k) clearance on 2023-03-23, under approval number K223419.

What company makes Triever16 Curve?

Triever16 Curve is manufactured by Inari Medical.

What is the FDA product code for Triever16 Curve?

The FDA product code for Triever16 Curve is QEW.

Related Clinical Trials

NCT06600542 Inari VISION Registry RECRUITING NCT06453876 Percutaneous Embolectomy, Low Dose Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism (STRATIFY II) NOT_YET_RECRUITING

Other Devices by Inari Medical

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath K183198FlowTriever Retrieval/Aspiration System K182233FlowTriever Retrieval/Aspiration System K182531ClotTriever Thrombectomy System K181694FlowTriever Retrieval/Aspiration System

View all 25 devices →

Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. 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.

↑