Cleared Special

K152335 - Export Advance Aspiration Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K152335 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
30d
Days
Class 2
Risk

K152335 is an FDA 510(k) clearance for the Export Advance Aspiration Catheter. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Medtronic, Inc. (Danvers, US). The FDA issued a Cleared decision on September 18, 2015 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K152335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2015
Decision Date September 18, 2015
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 Peers - DXE Catheter, Embolectomy

All 73
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K152335.
Fogarty Thru-Lumen Embolectomy Catheter
K240078 · Edwards Lifesciences, LLC · Aug 2024
Fogarty Fortis Arterial Embolectomy Catheter
K241330 · Edwards Lifesciences · Jul 2024
Fogarty Venous Thrombectomy Catheters
K233819 · Edwards Lifesciences, LLC · May 2024
Fogarty Arterial Embolectomy Catheter with Gate Valve
K233820 · Edwards Lifesciences · May 2024
Fogarty Corkscrew Catheters
K233619 · Edwards Lifesciences · May 2024
Merlin Aspiration System
K213771 · Mivi Neurovascular, Inc. · Jan 2022