MANIFOLD

Oxygenator, Cardiopulmonary Bypass

AMERICAN PHARMASEAL DIV. AHSC

The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Manifold.

Pre-market Notification Details

• Device ID: K811004
• 510k Number: K811004
• Device Name: MANIFOLD
• Classification: Oxygenator, Cardiopulmonary Bypass
• Applicant: AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DTZ
• CFR Regulation Number: 870.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-04-13
• Decision Date: 1981-05-08