CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX

Set, Administration, Intravascular

ICU MEDICAL INC

The following data is part of a premarket notification filed by Icu Medical Inc with the FDA for Chemoclave Cytotoxic Medication Preparation And Delivery System, Model, Ch-xxxx.

Pre-market Notification Details

• Device ID: K081361
• 510k Number: K081361
• Device Name: CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
• 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: 2008-05-15
• Decision Date: 2008-08-28
• Summary: summary

NIH GUDID Devices

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