Occlusion Perfusion Catheter

FDA 510(k) K151554 · Advanced Catheter Therapies, Inc.

Substantially Equivalent

510(k) numberK151554

Submission

Device name
Occlusion Perfusion Catheter
Applicant
Advanced Catheter Therapies, Inc.
Chattanooga, TN, US
Received
June 9, 2015
Decision date
September 15, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
QEY – Mechanical Thrombolysis Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Specialty
Cardiovascular

To mechanically disrupt thrombus and/or debris in the peripheral vasculature.

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K213422EkoSonic Endovascular Device, EKOS+ Endovascular DeviceQEY · Traditional Boston Scientific Corporation12/14/2021SE
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K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…QEY · Traditional Thrombolex, Inc.06/10/2021SE
K202347UNIFUSE Infusion System with Cooper WireQEY · Special AngioDynamics, Inc.09/15/2020SE

More from AngioDynamics, Inc.

510(k)DeviceDecision
K153488Occlusion Perfusion CatheterQEY · Traditional 02/25/2016SE
K130525Occlusion Perfusion CatheterDQY · Traditional 10/03/2013SE

Questions and answers

When was Occlusion Perfusion Catheter cleared by the FDA?

Occlusion Perfusion Catheter (K151554) received a 510(k) decision of Substantially Equivalent on September 15, 2015, 98 days after the submission was received.

What is the product code of K151554?

The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.