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 · Imperative Care, Inc. · Neurology

Apr 2019

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K183043 is an FDA 510(k) clearance for the 0.071? ID MantaRay Reperfusion Catheter, 0.055? ID MantaRay Reperfusion Catheter, 0.045? ID MantaRay Reperfusion Catheter, 0.035? ID MantaRay Reperfusion Catheter, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on April 17, 2019, 166 days after receiving the submission on November 2, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K183043 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NRY — Catheter, Thrombus Retriever
Device Class	Class II — 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.