Cleared Traditional

HIGH PRESSURE CONNECTING SETS, MODIFICATION

K914987 · E-Z-Em, Inc. · Cardiovascular

May 1992

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K914987 is an FDA 510(k) clearance for the HIGH PRESSURE CONNECTING SETS, MODIFICATION, a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II — Special Controls, product code DTL), submitted by E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on May 20, 1992, 209 days after receiving the submission on October 24, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4290.

Submission Details

510(k) Number	K914987 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 1991
Decision Date	May 20, 1992
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement

Device Classification

Product Code	DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4290