Cleared Traditional

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set

K234083 · Balt USA, LLC · Neurology

Jul 2024

Decision

193d

Days

Class 2

Risk

About This 510(k) Submission

K234083 is an FDA 510(k) clearance for the Next Generation Aspiration Catheter; Balt Aspiration Tubing Set, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on July 2, 2024, 193 days after receiving the submission on December 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K234083 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2023
Decision Date	July 02, 2024
Days to Decision	193 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.