Cleared Traditional

ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR

K926250 · Electromedics, Inc. · Cardiovascular
Feb 1993
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K926250 is an FDA 510(k) clearance for the ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on February 19, 1993, 67 days after receiving the submission on December 14, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number K926250 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1992
Decision Date February 19, 1993
Days to Decision 67 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DTN — Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4400

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