CLAVE NEUTRON

Set, Administration, Intravascular

ICU MEDICAL, INC.

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

Pre-market Notification Details

• Device ID: K100434
• 510k Number: K100434
• Device Name: CLAVE NEUTRON
• Classification: Set, Administration, Intravascular
• Applicant: ICU MEDICAL, INC. 4455 ATHERTON DRIVE Salt Lake City, UT 84123
• Contact: Tracy Best
• Correspondent: Tracy Best; ICU MEDICAL, INC. 4455 ATHERTON DRIVE Salt Lake City, UT 84123
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-02-16
• Decision Date: 2010-07-09
• Summary: summary