SHILEY ARTERIAL FILTER W/40 MICRON SCREE

K812742 · Shiley, Inc. · DTM · Nov 2, 1981 · Cardiovascular

Device Facts

• Record ID: K812742
• Device Name: SHILEY ARTERIAL FILTER W/40 MICRON SCREE
• Applicant: Shiley, Inc.
• Product Code: DTM · Cardiovascular
• Decision Date: Nov 2, 1981
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4260
• Device Class: Class 2

Regulatory Classification

Identification

A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

Special Controls

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