Cleared Traditional

K213435 - MAGIC Flow-Dependent Microcatheter (FDA 510(k) Clearance)

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

K213435 · Balt USA, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
270d
Days
Class 2
Risk

K213435 is an FDA 510(k) clearance for the MAGIC Flow-Dependent Microcatheter. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on July 19, 2022 after a review of 270 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 Balt USA, LLC devices

Submission Details

510(k) Number K213435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2021
Decision Date July 19, 2022
Days to Decision 270 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
122d slower than avg
Panel avg: 148d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 172
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K213435.
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