Cleared Traditional

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM

K910991 · Shiley, Inc. · Anesthesiology
Nov 1991
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K910991 is an FDA 510(k) clearance for the SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on November 27, 1991, 265 days after receiving the submission on March 7, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K910991 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1991
Decision Date November 27, 1991
Days to Decision 265 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAC — Apparatus, Autotransfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5830

Similar Devices — CAC Apparatus, Autotransfusion

All 194
XTRA Collection sets; XTRA Sequestration set X
K241236 · Sorin Group Italia S.R.L. · Aug 2024
Aventus Clot Management System
K240426 · Inquis Medical · May 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · Sorin Group Italia S.R.L. · Apr 2024
FlowSaver Blood Return System (80-101)
K231782 · Inari Medical, Inc. · Jul 2023
FlowSaver Blood Return System
K221483 · Inari Medical, Inc. · Feb 2023
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
K221722 · Haemonetics Corporation · Nov 2022