STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE

K925661 · Sorin Biomedica, Fiat, USA, Inc. · KRL · May 18, 1993 · Cardiovascular

Device Facts

• Record ID: K925661
• Device Name: STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
• Applicant: Sorin Biomedica, Fiat, USA, Inc.
• Product Code: KRL · Cardiovascular
• Decision Date: May 18, 1993
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4205
• Device Class: Class 2

Regulatory Classification

Identification

A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.