Cleared Traditional

DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT

K931552 · Davol, Inc. · Anesthesiology
Oct 1993
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K931552 is an FDA 510(k) clearance for the DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on October 8, 1993, 193 days after receiving the submission on March 29, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K931552 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 1993
Decision Date October 08, 1993
Days to Decision 193 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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