LOPEZ VALVE

Check Valve, Retrograde Flow (in-line)

ICU MEDICAL, INC.

The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Lopez Valve.

Pre-market Notification Details

• Device ID: K861586
• 510k Number: K861586
• Device Name: LOPEZ VALVE
• Classification: Check Valve, Retrograde Flow (in-line)
• Applicant: ICU MEDICAL, INC. 5200 WARNER AVENUE, STE. 108 Huntington Beach, CA 92649
• Contact: George A Lopez
• Correspondent: George A Lopez; ICU MEDICAL, INC. 5200 WARNER AVENUE, STE. 108 Huntington Beach, CA 92649
• Product Code: MJF
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-04-29
• Decision Date: 1986-08-18