Cleared Traditional

QUICK-SERTER, MODEL 395

K992300 · Medtronic Minimed · General Hospital
Jul 1999
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K992300 is an FDA 510(k) clearance for the QUICK-SERTER, MODEL 395, a Introducer, Syringe Needle (Class II — Special Controls, product code KZH), submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on July 29, 1999, 21 days after receiving the submission on July 8, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6920.

Submission Details

510(k) Number K992300 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1999
Decision Date July 29, 1999
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZH — Introducer, Syringe Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6920