PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR

K901250 · Shiley, Inc. · DTZ · Jun 11, 1990 · Cardiovascular

Device Facts

• Record ID: K901250
• Device Name: PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR
• Applicant: Shiley, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Jun 11, 1990
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2

Regulatory Classification

Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”