Cleared Traditional

Next Generation Aspiration Catheter (K234083) - FDA 510(k) Clearance

Also marketed or referenced as:
Balt Aspiration Tubing Set

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K234083 · Balt USA, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
193d
Days
Class 2
Risk

K234083 is an FDA 510(k) clearance for the Next Generation Aspiration Catheter. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on July 2, 2024 after a review of 193 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Balt USA, LLC devices

Submission Details

510(k) Number K234083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 148d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 72
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K234083.
CEREGLIDE 42 Intermediate Catheter
K241221 · Cerenovus, Inc. · Oct 2024
Esperance 3+ Aspiration Catheter System
K240917 · Wallaby Medical · Oct 2024
Millipede 088 Access Catheter
K242504 · Perfuze, Ltd. · Sep 2024
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
K233329 · Route 92 Medical, Inc. · Apr 2024
APRO 55 Catheter and Alembic Aspiration Tubing
K232971 · Alembic, LLC · Feb 2024
Cerenovus Large Bore Catheter
K233988 · Cerenovus, Inc. · Jan 2024