Cleared Traditional

PRESSURE DISPLAY BOX #60000/TUBING SET #61000

K852232 · Dlp, Inc. · Cardiovascular
Aug 1985
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K852232 is an FDA 510(k) clearance for the PRESSURE DISPLAY BOX #60000/TUBING SET #61000, a Gauge, Pressure, Coronary, Cardiopulmonary Bypass (Class II — Special Controls, product code DXS), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on August 9, 1985, 79 days after receiving the submission on May 22, 1985. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4310.

Submission Details

510(k) Number K852232 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1985
Decision Date August 09, 1985
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DXS — Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4310

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