Cleared Traditional

K233205 - Distal Access Catheter (FDA 510(k) Clearance)

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

K233205 · Shanghai Heartcare Medical Technology Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
85d
Days
Class 2
Risk

K233205 is an FDA 510(k) clearance for the Distal Access Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Shanghai Heartcare Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 22, 2023 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shanghai Heartcare Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K233205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date December 22, 2023
Days to Decision 85 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
63d faster than avg
Panel avg: 148d · This submission: 85d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QJP Catheter, Percutaneous, Neurovasculature

All 88
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K233205.
BosCATH Support Catheter
K254046 · Sonorous NV, Inc. · Apr 2026
Next Generation 088 Catheter
K254223 · Balt USA, LLC · Apr 2026
PATH BGC
K260938 · Crossroads Neurovascular, Inc. · Apr 2026
Radical 6F Access Catheter
K253975 · Maduro Medical, Inc. · Apr 2026
AXS Lift Intracranial Base Catheter
K253032 · Stryker Neurovascular · Feb 2026
Toro 88 Superbore Catheter
K252297 · Toro Neurovascular, Inc. · Jan 2026