Cleared Traditional

Raptor Aspiration Catheter; Balt Aspiration Tubing Set

K243948 · Balt USA, LLC · Neurology

Jun 2025

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K243948 is an FDA 510(k) clearance for the Raptor 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 June 3, 2025, 162 days after receiving the submission on December 23, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K243948 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2024
Decision Date	June 03, 2025
Days to Decision	162 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.