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TYSHAK - Model 302

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K991977

by NuMED, Inc.

Identifiers

510(k) Number
K991977 FDA 510(k)
FDA Product Code
LIT FDA 510(k)
Models / Variants
102 FDA 510(k)EUDAMED
Z-Med FDA 510(k)EUDAMED
Model 302 FDA 510(k)EUDAMED

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 Tyshak, Model 102 and Z-Med, Model 302 are angioplasty catheters designed for transluminal peripheral interventions. These devices are intended to mechanically dilate occluded or stenotic blood vessels in peripheral arteries, improving blood flow through the affected region.

These catheters are supplied as single-use devices and are classified as Class II under the FDA’s regulation number 870.1250. They are intended for use in clinical settings such as cardiac catheterization labs and interventional radiology suites. The devices are not MRI-safe and must be stored in a clean, dry environment as per manufacturer instructions. Authorized under FDA 510K and MDD compliance, they are regulated for cardiovascular applications.

Frequently asked questions

What clinical environments are the Tyshak (Model 102) and Z-Med (Model 302) catheters intended for use in?

These catheters are specifically designed for use in specialized clinical settings such as cardiac catheterization labs and interventional radiology suites, where peripheral vascular interventions are performed. Their purpose is to mechanically dilate occluded or stenotic blood vessels in peripheral arteries, improving blood flow in those regions.

Are the Tyshak and Z-Med catheters reusable or single-use devices?

The Tyshak (Model 102) and Z-Med (Model 302) catheters are explicitly supplied as single-use devices. This design ensures patient safety and sterility, as they are not intended for reuse.

How should the Tyshak and Z-Med catheters be stored according to manufacturer instructions?

The manufacturer recommends storing these catheters in a clean, dry environment. This ensures the integrity of the device and maintains its readiness for use in clinical settings.

What regulatory pathways have the Tyshak and Z-Med catheters followed for approval?

The Tyshak (Model 102) and Z-Med (Model 302) catheters are authorized under the FDA’s 510K pathway and comply with the Medical Device Directive (MDD). They are classified as Class II devices under FDA regulation number 870.1250, with a decision of ‘Substantially Equivalent’ by the Cardiovascular (CV) advisory committee.

Are the Tyshak and Z-Med catheters compatible with MRI equipment?

No, the Tyshak and Z-Med catheters are explicitly stated as not MRI-safe. This means they should not be used in or near MRI machines, as the magnetic fields could pose risks to the device or the patient.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
NuMED, Inc.

Sources (2)

  • FDA 510(k) K991977 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 13, 2026