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FDA 510(k)

Occlusion Perfusion Catheter

K-Number: K153488 · 2016-02-25

ApplicantAdvanced Catheter Therapies, Inc.
Decision Date2016-02-25
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Occlusion Perfusion Catheter is a medical device manufactured by Advanced Catheter Therapies, Inc.. It received FDA 510(k) clearance on 2016-02-25 under approval number K153488. 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 Occlusion Perfusion Catheter?

Occlusion Perfusion Catheter is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by Advanced Catheter Therapies, Inc.. The 510(k) number is K153488.

When was Occlusion Perfusion Catheter approved by the FDA?

Occlusion Perfusion Catheter received FDA 510(k) clearance on 2016-02-25, under approval number K153488.

What company makes Occlusion Perfusion Catheter?

Occlusion Perfusion Catheter is manufactured by Advanced Catheter Therapies, Inc..

What is the FDA product code for Occlusion Perfusion Catheter?

The FDA product code for Occlusion Perfusion Catheter is QEY.

Related Clinical Trials

NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING NCT06795763 Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures ENROLLING_BY_INVITATION NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07527299 A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation NOT_YET_RECRUITING NCT07219758 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK) RECRUITING

Related Devices (Code: QEY)

K162777Squirt Fluid Delivery SystemMerit Medical Systems, 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. K193071Bashir Plus Endovascular CatheterThrombolex, 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.

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