Cleared Traditional

K172448 - Riptide Aspiration System

K172448 is an FDA 510(k) clearance for Riptide Aspiration System, manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The device is a Class 2 Neurology device with product code NRY cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K172448 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
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Dec 2017
Decision
129d
Days
Class 2
Risk

K172448 is an FDA 510(k) clearance for the Riptide Aspiration System. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on December 21, 2017 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro Therapeutics, Inc. d/b/a ev3 Neurovascular devices

FDA 510(k) Submission Details - K172448

510(k) Number K172448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2017
Decision Date December 21, 2017
Days to Decision 129 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 148d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NRY Device Classification - Class 2, Special Controls

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
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 Neurology devices follow this clearance model.

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 106
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K172448.
EmboTrap ll Revascularization Device
K173452 · Neuravi, Ltd. · May 2018
Zenith Flex System
K172167 · Inneuroco, Inc. · Apr 2018
AXS Catalyst Distal Access Catheter 058 x 115cm
K173841 · Stryker · Mar 2018
Penumbra 3D Revascularization Device
K162901 · Penumbra, Inc. · Apr 2017
Solitaire Platinum Revascularization Device, 6x40 mm
K160641 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Mar 2017
Solitaire Platinum Revascularization Device
K161879 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Sep 2016