21 CFR 870.4270 — Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4270

Identification

A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass2123rd Party
Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...