Cleared Traditional

SOS BLOODLESS NEEDLE

K914330 · E-Z-Em, Inc. · Cardiovascular
Dec 1991
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K914330 is an FDA 510(k) clearance for the SOS BLOODLESS NEEDLE, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on December 20, 1991, 84 days after receiving the submission on September 27, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K914330 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 1991
Decision Date December 20, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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