Cleared Traditional

K202366 - MAGIC Infusion Catheter

K202366 is an FDA 510(k) clearance for MAGIC Infusion Catheter, manufactured by Balt USA, LLC. The device is a Class 2 Neurology device with product code KRA cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K202366 · Balt USA, LLC · Neurology device
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Jan 2021
Decision
163d
Days
Class 2
Risk

K202366 is an FDA 510(k) clearance for the MAGIC Infusion Catheter. 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 January 29, 2021 after a review of 163 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

FDA 510(k) Submission Details - K202366

510(k) Number K202366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2020
Decision Date January 29, 2021
Days to Decision 163 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
15d slower than avg
Panel avg: 148d · This submission: 163d
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 K202366.
SwiftNINJA Steerable Microcatheter
K211525 · Merit Medical Systems, Inc. · Jul 2021
Instylla Microcatheter 1.2
K210808 · Instylla, Inc. · Apr 2021
Rebar Micro Catheter
K210114 · Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · Feb 2021
Marathon Flow Directed Micro Catheter
K202318 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Sep 2020
Fountain ValveTip Infusion Catheter
K193082 · Merit Medical Systems, Inc. · Aug 2020
ClariVein IC
K201907 · Merit Medical Systems, Inc. · Aug 2020