CLAVE STOPCOCK

Stopcock, I.v. Set

ICU MEDICAL, INC

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

Pre-market Notification Details

• Device ID: K080077
• 510k Number: K080077
• Device Name: CLAVE STOPCOCK
• Classification: Stopcock, I.v. Set
• Applicant: ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123
• Contact: Tracy Best
• Correspondent: Tracy Best; ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123
• Product Code: FMG
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-01-11
• Decision Date: 2008-02-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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