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Spartan MC 0165

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213451

by Spartan Micro

Identifiers

510(k) Number
K213451 FDA 510(k)
FDA Product Code
QJP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Spartan MC 0165 is a percutaneous neurovasculature catheter designed for the introduction of interventional devices or infusion of diagnostic agents into neuro, peripheral, and coronary blood vessels. Its single-lumen design, 0.0165-inch inner diameter, and variable stiffness composite body enable precise navigation through vascular pathways. Radiopaque distal marker bands enhance fluoroscopic visualization during procedures.

This device is supplied as a sterile, single-use microcatheter and is classified under FDA product code QJP as a Class II device with special controls. It is intended for use in interventional radiology and cardiology settings, where its small profile and flexibility support access to complex vascular territories. The device requires proper storage in a clean, dry environment to maintain sterility and functionality. Its regulatory clearance (FDA 510(k) K213451) confirms compliance with applicable standards for neurovascular catheters.

Frequently asked questions

What is the Spartan MC 0165 primarily used for in clinical settings?

The Spartan MC 0165 is designed for percutaneous neurovascular procedures, allowing interventional devices or diagnostic agents to be introduced into neuro, peripheral, and coronary blood vessels. Its small inner diameter (0.0165-inch) and flexible composite body enable precise navigation through complex vascular pathways, making it suitable for use in interventional radiology and cardiology.

Is the Spartan MC 0165 intended for single-use or repeated use, and how should it be stored?

The Spartan MC 0165 is supplied as a sterile, single-use microcatheter. To maintain sterility and functionality, it must be stored in a clean, dry environment as specified by the manufacturer.

What regulatory pathway was followed for the FDA clearance of the Spartan MC 0165?

The Spartan MC 0165 received FDA clearance through a traditional 510(k) pathway (K213451), with a decision of substantially equivalent (SESE) under product code QJP. The device was reviewed by the Cardiovascular (CV) advisory committee and classified as a Class II device with special controls.

How does the design of the Spartan MC 0165 support its use in fluoroscopic procedures?

The Spartan MC 0165 features radiopaque distal marker bands, which enhance visibility under fluoroscopy. This design ensures better tracking and positioning during procedures, particularly in complex vascular territories.

What medical specialties are most likely to use the Spartan MC 0165?

The Spartan MC 0165 is primarily intended for use in interventional radiology and cardiology, where its small profile and flexibility are advantageous for accessing neurovascular, peripheral, and coronary blood vessels.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Spartan MC 0165 (K213451) — FDA 510 (k) | Innolitics, K213451 - Spartan MC 0165 | FDA 510 (k) | Spartan Micro, Spartan Micro Receives FDA 510k Clearance for its MC 0165 Microcatheter

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spartan Micro

Sources (1)

  • FDA 510(k) K213451 24 fields · synced Sep 20, 2026