TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES

Tube, Tracheal (w/wo Connector)

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes.

Pre-market Notification Details

• Device ID: K090352
• 510k Number: K090352
• Device Name: TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
• Classification: Tube, Tracheal (w/wo Connector)
• Applicant: COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80516
• Contact: Ted Kuhn
• Correspondent: Ted Kuhn; COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80516
• Product Code: BTR
• CFR Regulation Number: 868.5730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-11
• Decision Date: 2009-04-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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20884522007532	K090352	000
70884522007575	K090352	000