Cleared Traditional

Next Generation Access Catheter (K234074) - FDA 510(k) Clearance

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

K234074 · 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

K234074 is an FDA 510(k) clearance for the Next Generation Access Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), 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 K234074 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 QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
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 - QJP Catheter, Percutaneous, Neurovasculature

All 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K234074.
Zipline Access Catheter
K240711 · Perfuze, Ltd. · Oct 2024
CEREGLIDE 42 Intermediate Catheter
K241244 · Cerenovus, Inc. · Oct 2024
8F Modified Sheath System
K240529 · Route 92 Medical, Inc. · Oct 2024
TracStar LDP Large Distal Platform
K240948 · Imperative Care, Inc. · Jun 2024
Wedge XL Delivery Catheter
K232542 · MicroVention, Inc. · May 2024
CEREGLIDE 92 Catheter System
K233982 · Cerenovus, Inc. · May 2024