SAFE II

Oxygenator, Cardiopulmonary Bypass

POLYSTAN A/S

The following data is part of a premarket notification filed by Polystan A/s with the FDA for Safe Ii.

Pre-market Notification Details

• Device ID: K912082
• 510k Number: K912082
• Device Name: SAFE II
• Classification: Oxygenator, Cardiopulmonary Bypass
• Applicant: POLYSTAN A/S 8, WALGERHOLM DK-3500 VAERLOSE Denmark, DK
• Contact: Moe Haveland
• Correspondent: Moe Haveland; POLYSTAN A/S 8, WALGERHOLM DK-3500 VAERLOSE Denmark, DK
• Product Code: DTZ
• CFR Regulation Number: 870.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-05-10
• Decision Date: 1991-12-04