Cleared Traditional

K243534 - Micro Catheter

K243534 is an FDA 510(k) clearance for Micro Catheter, manufactured by Suzhou Zenith Vascular SciTech Limited. The device is a Class 2 Neurology device with product code KRA cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K243534 · Suzhou Zenith Vascular SciTech Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
257d
Days
Class 2
Risk

K243534 is an FDA 510(k) clearance for the Micro Catheter. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Suzhou Zenith Vascular SciTech Limited (Suzhou, CN). The FDA issued a Cleared decision on July 30, 2025 after a review of 257 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1210 - 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 Suzhou Zenith Vascular SciTech Limited devices

FDA 510(k) Submission Details - K243534

510(k) Number K243534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2024
Decision Date July 30, 2025
Days to Decision 257 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
109d slower than avg
Panel avg: 148d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 130
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K243534.
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