Cleared Traditional

K183043 - 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 105
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K183043.
Millipede System
K253590 · Perfuze, Ltd. · Mar 2026
Tigertriever 25 Revascularization Device
K253062 · Rapid Medical , Ltd. · Mar 2026
Esperance pHLO Aspiration System
K251357 · Phenox, Ltd. · Jan 2026
NeVasc Aspiration System
K251006 · Vesalio, Inc. · Nov 2025
Zoom System (Zoom 4S Catheter)
K252046 · Imperative Care, Inc. · Oct 2025
Tigertriever 17 Ultra Revascularization Device
K251603 · Rapid Medical , Ltd. · Oct 2025