CLAVE CONNECTOR

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 Connector.

Pre-market Notification Details

• Device ID: K970855
• 510k Number: K970855
• Device Name: CLAVE CONNECTOR
• Classification: Set, Administration, Intravascular
• Applicant: ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673
• Contact: Arlene Dutchik
• Correspondent: Arlene Dutchik; ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-03-10
• Decision Date: 1997-06-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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