Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray,

Tube Tracheostomy And Tube Cuff

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Blue Rhino G1-multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-multi Percutaneous Tracheostomy Introducer Tray, .

Pre-market Notification Details

• Device ID: K193133
• 510k Number: K193133
• Device Name: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray,
• Classification: Tube Tracheostomy And Tube Cuff
• Applicant: Cook Incorporated 750 Daniels Way Bloomington, IN 47404
• Contact: Irasema Rivera
• Correspondent: Irasema Rivera; Cook Incorporated 750 Daniels Way Bloomington, IN 47404
• Product Code: JOH
• CFR Regulation Number: 868.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-11-12
• Decision Date: 2019-12-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00827002577039	K193133	000
00827002576896	K193133	000
00827002576902	K193133	000
00827002576919	K193133	000
00827002576926	K193133	000
00827002576933	K193133	000
00827002576940	K193133	000
00827002576957	K193133	000
00827002576964	K193133	000
00827002576971	K193133	000
00827002576988	K193133	000
00827002576889	K193133	000
00827002576872	K193133	000
00827002576865	K193133	000
00827002577046	K193133	000
00827002577169	K193133	000
00827002577176	K193133	000
00827002577183	K193133	000
00827002577190	K193133	000
00827002575943	K193133	000
00827002576827	K193133	000
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00827002576841	K193133	000
00827002576858	K193133	000
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00827002577237	K193133	000
00827002577244	K193133	000
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00827002577268	K193133	000
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00827002577022	K193133	000
00827002577060	K193133	000
00827002577077	K193133	000
00827002577084	K193133	000
00827002577091	K193133	000
00827002577107	K193133	000
00827002577114	K193133	000
00827002577121	K193133	000
00827002577138	K193133	000
00827002577312	K193133	000