Cleared Traditional

ANGIOGRAPHIC FLUSH SYSTEM

K914113 · E-Z-Em, Inc. · General Hospital
Jan 1992
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K914113 is an FDA 510(k) clearance for the ANGIOGRAPHIC FLUSH SYSTEM, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on January 22, 1992, 131 days after receiving the submission on September 13, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K914113 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1991
Decision Date January 22, 1992
Days to Decision 131 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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