Lunderquist® Fixed Core Wire Guide

Wire, Guide, Catheter

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Lunderquist® Fixed Core Wire Guide.

Pre-market Notification Details

• Device ID: K181353
• 510k Number: K181353
• Device Name: Lunderquist® Fixed Core Wire Guide
• Classification: Wire, Guide, Catheter
• Applicant: Cook Incorporated 750 Daniels Way Bloomington, IN 47402
• Contact: Jennifer L. Allman
• Correspondent: Jennifer Allman; Cook Incorporated 750 Daniels Way Bloomington, IN 47402
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-05-22
• Decision Date: 2019-02-15
• Summary: summary