Cleared Traditional

0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter (K183043) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183043 · Imperative Care, Inc. · Neurology device
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Apr 2019
Decision
166d
Days
Class 2
Risk

K183043 is an FDA 510(k) clearance for the 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Cathe.... Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on April 17, 2019 after a review of 166 days - an extended review cycle.

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 Imperative Care, Inc. devices

Submission Details

510(k) Number K183043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2018
Decision Date April 17, 2019
Days to Decision 166 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
18d slower than avg
Panel avg: 148d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 72
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K183043.
Penumbra System Reperfusion Catheter JET 7
K190010 · Penumbra, Inc. · Jun 2019
Penumbra System 3D Revascularization Device
K190464 · Penumbra, Inc. · Apr 2019
AXS Vecta Aspiration System
K190212 · Stryker Neurovascular · Apr 2019
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
K183464 · Stryker · Mar 2019
Riptide Aspiration System (Riptide Large Bore Aspiration System)
K183185 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Dec 2018
Riptide Aspiration System (React 71 Catheter)
K182101 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Nov 2018