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)

Bashir Plus Endovascular Catheter

K-Number: K193071 · 2019-12-17

ApplicantThrombolex, Inc.
Decision Date2019-12-17
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bashir Plus Endovascular Catheter is a medical device manufactured by Thrombolex, Inc.. It received FDA 510(k) clearance on 2019-12-17 under approval number K193071. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bashir Plus Endovascular Catheter?

Bashir Plus Endovascular Catheter is a medical device that received FDA 510(k) clearance on 2019-12-17. It is manufactured by Thrombolex, Inc.. The 510(k) number is K193071.

When was Bashir Plus Endovascular Catheter approved by the FDA?

Bashir Plus Endovascular Catheter received FDA 510(k) clearance on 2019-12-17, under approval number K193071.

What company makes Bashir Plus Endovascular Catheter?

Bashir Plus Endovascular Catheter is manufactured by Thrombolex, Inc..

What is the FDA product code for Bashir Plus Endovascular Catheter?

The FDA product code for Bashir Plus Endovascular Catheter is QEY.

Related Clinical Trials

NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT06588543 Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping RECRUITING NCT04790370 Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism ACTIVE_NOT_RECRUITING NCT07542938 Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis NOT_YET_RECRUITING

Other Devices by Thrombolex, Inc.

K192598Bashir S-B Endovascular Catheter, Ref. No. 7101 K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101

Related Devices (Code: QEY)

K162777Squirt Fluid Delivery SystemMerit Medical Systems, Inc. K153488Occlusion Perfusion CatheterAdvanced Catheter Therapies, Inc. K163356Pulse* Spray Infusion System, Uni*Fuse Infusion SystemAngioDynamics, Inc. K162771EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. K170258SpeedLyser Infusion Catheter KitAngioDynamics, Inc. K182324EkoSonic Endovascular SystemBtg International, 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.

↑