SMARTVALVE

Set, Administration, Intravascular

ICU MEDICAL, INC.

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

Pre-market Notification Details

• Device ID: K974589
• 510k Number: K974589
• Device Name: SMARTVALVE
• Classification: Set, Administration, Intravascular
• Applicant: ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673
• Contact: Salvadore F Palomares
• Correspondent: Salvadore F Palomares; 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: 1997-12-09
• Decision Date: 1998-01-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10887709074702	K974589	000
10887709025452	K974589	000
10887709025414	K974589	000
10887709025100	K974589	000
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10887709042114	K974589	000
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