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Wire, Guide, Catheter

by Lake Region Mfg., Inc.

510(k) K850829

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK850829 Date26 Jun 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a wire, guide, catheter used to guide catheters and other instruments during medical procedures. It provides a pathway for diagnostic or therapeutic devices to reach target anatomical sites.

The device is supplied as a single-use item and is intended for sterile use. It is classified under product code DQY and was authorized under FDA 510(k) clearance K850829. Storage conditions and specific sizes are not detailed in the available specifications.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is this device used for?

    This guide wire is used to guide catheters and other medical instruments during procedures, providing a pathway to reach specific anatomical sites for diagnosis or treatment.

  • How is the device supplied?

    It is supplied as a single-use item and is intended for sterile use, meaning it is provided in a sterile format ready for clinical application.

  • Is this device reusable?

    No, it is designed for single use only. Reuse could compromise sterility and structural integrity, posing risks to patient safety.

  • What regulatory path did it follow?

    It was authorized under the FDA 510(k) premarket notification process with clearance number K850829, classified under product code DQY for cardiovascular devices.

  • What storage conditions apply?

    Specific storage conditions are not detailed in the available specifications, but standard medical device storage typically involves a dry, controlled environment away from extreme temperatures.