Cleared Traditional

GSI CANNULA WITH INTRODUCER

K970201 · General Surgical Innovations · Cardiovascular
Apr 1997
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K970201 is an FDA 510(k) clearance for the GSI CANNULA WITH INTRODUCER, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by General Surgical Innovations (Palo Alto, US). The FDA issued a Cleared decision on April 21, 1997, 90 days after receiving the submission on January 21, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K970201 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 1997
Decision Date April 21, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340