Cleared Traditional

K153488 - Occlusion Perfusion Catheter

K153488 is an FDA 510(k) clearance for Occlusion Perfusion Catheter, manufactured by Advanced Catheter Therapies, Inc.. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K153488 · Advanced Catheter Therapies, Inc. · Cardiovascular device
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Feb 2016
Decision
83d
Days
Class 2
Risk

K153488 is an FDA 510(k) clearance for the Occlusion Perfusion Catheter. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Advanced Catheter Therapies, Inc. (Chattanooga, US). The FDA issued a Cleared decision on February 25, 2016 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K153488

510(k) Number K153488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2015
Decision Date February 25, 2016
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEY Device Classification - Class 2, Special Controls

Product Code QEY Mechanical Thrombolysis Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

The Braveheart Group, Inc.
Jeff Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QEY Mechanical Thrombolysis Catheter

All 66
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K153488.
EkoSonic Endovascular System with Control Unit 4.0
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Squirt Fluid Delivery System
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Occlusion Perfusion Catheter
K151554 · Advanced Catheter Therapies, Inc. · Sep 2015
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
K140151 · Btg International, Inc. · May 2014
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
K130904 · Covidien · Oct 2013