Cleared Traditional

Spartan MC 0165 (K213451) - FDA 510(k) Clearance

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

K213451 · Spartan Micro · Neurology device
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Nov 2021
Decision
27d
Days
Class 2
Risk

K213451 is an FDA 510(k) clearance for the Spartan MC 0165. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Spartan Micro (Fremont, US). The FDA issued a Cleared decision on November 22, 2021 after a review of 27 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 Spartan Micro devices

Submission Details

510(k) Number K213451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2021
Decision Date November 22, 2021
Days to Decision 27 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
121d faster than avg
Panel avg: 148d · This submission: 27d
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 K213451.
MIVI Q Distal Access Catheter
K212402 · Mivi Neuroscience, Inc. · Dec 2021
Branchor Balloon Guide Catheter
K203723 · Asahi Intecc Co., Ltd. · Dec 2021
Trevo Trak 21 Microcatheter
K211594 · Stryker Neurovascular · Nov 2021
TracStar LDP Large Distal Platform
K212224 · Imperative Care, Inc. · Sep 2021
AXS Vecta 46 Intermediate Catheter
K202752 · Stryker Neurovascular · Aug 2021
Balloon Guiding Catheter
K202916 · Shanghai Heartcare Medical Technology Co., Ltd. · Aug 2021