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010 Hi-Tor Inter/Stand Guidwire Preshape Tip/Modif

FDA 510(k)

Class II (US FDA 510(k))

510(k) K914828

by Advanced Cardiovascular Systems, Inc.

Identifiers

510(k) Number
K914828 FDA 510(k)
FDA Product Code
DQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 010 Hi-Tor Inter/Stand Guidewire Preshape Tip/Modif is a catheter guide wire. It is designed to facilitate the placement of catheters within the cardiovascular system.

This device is identified by FDA 510(k) clearance K914828 and is classified under product code DQX. It is manufactured by Advanced Cardiovascular Systems, Inc. and is intended for use in cardiovascular procedures.

Frequently asked questions

What is the primary function of the 010 Hi-Tor Inter/Stand Guidewire?

This device is a catheter guide wire specifically designed to facilitate the accurate placement of catheters within the cardiovascular system during clinical procedures.

Who is the manufacturer of this guidewire?

The 010 Hi-Tor Inter/Stand Guidewire Preshape Tip/Modif is manufactured by Advanced Cardiovascular Systems, Inc., located in Santa Clara, California.

What is the regulatory status of this device?

This device has received FDA 510(k) clearance under the number K914828. It is classified under product code DQX and was determined to be substantially equivalent to existing devices by the cardiovascular advisory committee.

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: 010 Hi-tor Inter/Stand Guidwire Preshape Tip/Modif, K914828 - 010 Hi-tor Inter/Stand Guidwire Preshap..., 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF… - FDA.report, 510 (K) Premarket Notification

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Advanced Cardiovascular Systems, Inc.

Sources (1)

  • FDA 510(k) K914828 24 fields · synced Sep 22, 2026