← Back to catalogue

LUNDERQUIST WIRE GUIDE - Dc Wire Guide

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061670

by William Cook Europe ApS

Identifiers

510(k) Number
K061670 FDA 510(k)
FDA Product Code
DQX FDA 510(k)
Models / Variants
Dc Wire Guide 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)

LUNDERQUIST WIRE GUIDE - Dc Wire Guide by William Cook Europe ApS — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Sources (1)

  • FDA 510(k) K061670 24 fields · synced Jun 18, 2026