MAXIMA FILTERED HARDSHELL RESERVIOR

K933496 · Medtronic Vascular · DTP · Oct 15, 1993 · Cardiovascular

Device Facts

• Record ID: K933496
• Device Name: MAXIMA FILTERED HARDSHELL RESERVIOR
• Applicant: Medtronic Vascular
• Product Code: DTP · Cardiovascular
• Decision Date: Oct 15, 1993
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4230
• Device Class: Class 2

Regulatory Classification

Identification

A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”