Cleared Special

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

K210996 · Imperative Care, Inc. · Neurology

Apr 2021

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K210996 is an FDA 510(k) clearance for the ZOOM (71, 55, 45, 35) Reperfusion Catheters; 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 April 23, 2021, 21 days after receiving the submission on April 2, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K210996 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 2021
Decision Date	April 23, 2021
Days to Decision	21 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.