Cleared Traditional

SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200

K911876 · Shiley, Inc. · Cardiovascular
Aug 1991
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K911876 is an FDA 510(k) clearance for the SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on August 9, 1991, 102 days after receiving the submission on April 29, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number K911876 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1991
Decision Date August 09, 1991
Days to Decision 102 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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