Cleared Traditional

Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing

K243047 · Imperative Care, Inc. · Neurology

May 2025

Decision

243d

Days

Class 2

Risk

About This 510(k) Submission

K243047 is an FDA 510(k) clearance for the Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD 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 May 28, 2025, 243 days after receiving the submission on September 27, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K243047 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	May 28, 2025
Days to Decision	243 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.