Cleared Traditional

ANGIOGRAPHIC SOFT TIP CATHETER

K914199 · E-Z-Em, Inc. · Cardiovascular
Dec 1991
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K914199 is an FDA 510(k) clearance for the ANGIOGRAPHIC SOFT TIP CATHETER, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on December 18, 1991, 90 days after receiving the submission on September 19, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K914199 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1991
Decision Date December 18, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200

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