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)

Thrombuster II Aspiration Catheter

K-Number: K213166 · 2021-10-26

ApplicantKaneka Medical America, LLC
Decision Date2021-10-26
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Thrombuster II Aspiration Catheter is a medical device manufactured by Kaneka Medical America, LLC. It received FDA 510(k) clearance on 2021-10-26 under approval number K213166. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thrombuster II Aspiration Catheter?

Thrombuster II Aspiration Catheter is a medical device that received FDA 510(k) clearance on 2021-10-26. It is manufactured by Kaneka Medical America, LLC. The 510(k) number is K213166.

When was Thrombuster II Aspiration Catheter approved by the FDA?

Thrombuster II Aspiration Catheter received FDA 510(k) clearance on 2021-10-26, under approval number K213166.

What company makes Thrombuster II Aspiration Catheter?

Thrombuster II Aspiration Catheter is manufactured by Kaneka Medical America, LLC.

What is the FDA product code for Thrombuster II Aspiration Catheter?

The FDA product code for Thrombuster II Aspiration Catheter is QEZ.

Related Clinical Trials

NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED

Other Devices by Kaneka Medical America, LLC

K210638i-ED COIL System

Related Devices (Code: QEZ)

K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC K173266Octane aspiration systemVascular Solutions, Inc. K172000ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K182232Octane Mechanical Thrombectomy SystemVascular Solutions, Inc. K192439JETi Peripheral Thrombectomy SystemWalk Vascular, LLC

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.

↑