Cleared Traditional

K970994 - CORE AND COIL ASSEMBLY GUIDEWIRE
(FDA 510(k) Clearance)

K970994 · Lake Region Mfg., Inc. · Gastroenterology & Urology
Mar 1997
Decision
6d
Days
Class 1
Risk

K970994 is an FDA 510(k) clearance for the CORE AND COIL ASSEMBLY GUIDEWIRE, a Stylet For Catheter, Gastro-urology (Class I — General Controls, product code EZB), submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on March 25, 1997, 6 days after receiving the submission on March 19, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K970994 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 1997
Decision Date March 25, 1997
Days to Decision 6 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EZB — Stylet For Catheter, Gastro-urology
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5130