SPIROS

Set, Administration, Intravascular

ICU MEDICAL, INC

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

Pre-market Notification Details

• Device ID: K070532
• 510k Number: K070532
• Device Name: SPIROS
• Classification: Set, Administration, Intravascular
• Applicant: ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123
• Contact: Martin Maier
• Correspondent: Martin Maier; ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-26
• Decision Date: 2007-03-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10840619065673	K070532	000
10840619036468	K070532	000
10840619036796	K070532	000
10840619037021	K070532	000
10840619042766	K070532	000
10840619046405	K070532	000
10840619058873	K070532	000
10840619060654	K070532	000
10840619064430	K070532	000
10840619066281	K070532	000
10840619066540	K070532	000
10840619068278	K070532	000
10840619068360	K070532	000
10840619035201	K070532	000
10840619027282	K070532	000
10840619025684	K070532	000
10840619081741	K070532	000
10840619023291	K070532	000
10840619023307	K070532	000
10840619023338	K070532	000
10840619023369	K070532	000
10840619023796	K070532	000
10840619023819	K070532	000
10840619023826	K070532	000
10840619025233	K070532	000
10840619025332	K070532	000
10840619025660	K070532	000
10840619025677	K070532	000
10840619068513	K070532	000
10840619073722	K070532	000
10840619075993	K070532	000
10887709077994	K070532	000
10887709081144	K070532	000
10887709081229	K070532	000
10887709081458	K070532	000
10887709081564	K070532	000
10887709081984	K070532	000
10887709084039	K070532	000
10887709086521	K070532	000
10887709086880	K070532	000
10887709121598	K070532	000
10887709122199	K070532	000
10887709035833	K070532	000
10887709076898	K070532	000
10887709076348	K070532	000
10887709075167	K070532	000
10840619079083	K070532	000
10840619081734	K070532	000
10840619082359	K070532	000
10840619083431	K070532	000
10840619083585	K070532	000
10887709035260	K070532	000
10887709035420	K070532	000
10887709035734	K070532	000
10887709074054	K070532	000
10887709074078	K070532	000
10887709074726	K070532	000
10887709074795	K070532	000
10887709035901	K070532	000