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Turbo-Tandem System Model 472-110

FDA 510(k)

Class II (US FDA 510(k))

510(k) K094036

by Spectranetics Corp.

Identifiers

510(k) Number
K094036 FDA 510(k)
FDA Product Code
MCW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4875 FDA 510(k)
Regulation Number
870.4875 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Turbo-Tandem System Model 472-110 is a peripheral atherectomy catheter, designed for the mechanical removal of atherosclerotic plaque from infrainguinal arteries. Classified as a Class II device under FDA regulation 870.4875, it operates within the cardiovascular specialty and is intended for use in endovascular procedures to restore blood flow by excising obstructive lesions.

This device is supplied as a single-use, sterile catheter system and requires no additional sterilization. It is intended for use in controlled clinical settings, such as catheterization laboratories, and must be handled according to manufacturer guidelines to ensure proper functionality. The Turbo-Tandem System Model 472-110 holds an FDA 510(k) clearance (K094036) under the Special 510(k) Review Program, with a decision date of January 25, 2010, and is categorized under product code MCW. Storage conditions and MRI safety are not specified in the available data.

Frequently asked questions

What is the Turbo-Tandem System Model 472-110 used for?

The Turbo-Tandem System Model 472-110 is designed specifically for the mechanical removal of atherosclerotic plaque from infrainguinal arteries. It is intended to restore blood flow by excising obstructive lesions during endovascular procedures, making it suitable for patients with peripheral artery disease requiring intervention in lower limb arteries.

Is the Turbo-Tandem System Model 472-110 single-use or reusable?

The Turbo-Tandem System Model 472-110 is supplied as a single-use device. This design ensures patient safety by eliminating the risk of cross-contamination and maintains device performance for one procedure only, as recommended by the manufacturer.

How should the Turbo-Tandem System Model 472-110 be stored?

While the provided data does not specify detailed storage conditions, the device is supplied sterile and intended for single-use in controlled clinical settings like catheterization laboratories. It should be stored according to the manufacturer’s guidelines to preserve sterility and functionality until use.

What regulatory approval does the Turbo-Tandem System Model 472-110 hold?

The Turbo-Tandem System Model 472-110 holds an FDA 510(k) clearance under the Special 510(k) Review Program, with clearance number K094036. This classification confirms it is substantially equivalent to a legally marketed device and is categorized under product code MCW for peripheral atherectomy catheters.

Where can the Turbo-Tandem System Model 472-110 be used?

This device is intended for use in controlled clinical settings, such as catheterization laboratories, where endovascular procedures are performed. Its design and sterility make it suitable for direct use in removing obstructive plaque from infrainguinal arteries during surgical interventions.

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: AccessGUDID - DEVICE: Turbo Tandem™ (M2044721100), TURBO-TANDEM SYSTEM MODEL 472-110 - fda.innolitics.com, Turbo Tandem™ 472-110 Turbo-Tandem™ Laser Guide Catheter with Laser ..., TURBO-TANDEM SYSTEM MODEL 472-110 510(k) K094036 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spectranetics Corp.

Sources (1)

  • FDA 510(k) K094036 24 fields · synced Oct 1, 2026