Cleared Special

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing

K211476 · Imperative Care, Inc. · Neurology

Jun 2021

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K211476 is an FDA 510(k) clearance for the ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing, 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 June 8, 2021, 27 days after receiving the submission on May 12, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K211476 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2021
Decision Date	June 08, 2021
Days to Decision	27 days
Submission Type	Special
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.