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 IDK090352
510k NumberK090352
Device Name:TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
ClassificationTube, Tracheal (w/wo Connector)
Applicant COVIDIEN 6135 GUNBARREL AVE. Boulder,  CO  80516
ContactTed Kuhn
CorrespondentTed Kuhn
COVIDIEN 6135 GUNBARREL AVE. Boulder,  CO  80516
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-11
Decision Date2009-04-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521750330 K090352 000
30884521164554 K090352 000
30884521103850 K090352 000
20884521164526 K090352 000
20884521164533 K090352 000
20884521164540 K090352 000
30884521164509 K090352 000
30884521620173 K090352 000
10884521103849 K090352 000
30884521164516 K090352 000
30884521620203 K090352 000
20884521620138 K090352 000
20884521620145 K090352 000
20884521620152 K090352 000
30884521620166 K090352 000
30884521620180 K090352 000
30884521103867 K090352 000
20884521164564 K090352 000
30884521726677 K090352 000
20884521750323 K090352 000
10884521750340 K090352 000
20884521750354 K090352 000
10884521750364 K090352 000
20884521750378 K090352 000
20884521750385 K090352 000
30884522007584 K090352 000
30884521726684 K090352 000
30884521726691 K090352 000
20884521726700 K090352 000
20884521726717 K090352 000
30884521726721 K090352 000
30884521726738 K090352 000
20884522007549 K090352 000
30884522007638 K090352 000
20884521620190 K090352 000
30884521620210 K090352 000
60884521032533 K090352 000
50884521032543 K090352 000
60884521032557 K090352 000
50884521032567 K090352 000
60884522007547 K090352 000
40884522007567 K090352 000
60884522007578 K090352 000
60884522007585 K090352 000
60884522007592 K090352 000
60884522007608 K090352 000
40884522007611 K090352 000
60884522007622 K090352 000
60884522007639 K090352 000
40884522007642 K090352 000
50884522007533 K090352 000
50884521032529 K090352 000
60884521032519 K090352 000
50884521032499 K090352 000
30884521620227 K090352 000
20884522007594 K090352 000
30884522007607 K090352 000
20884522007617 K090352 000
20884522007624 K090352 000
30884522007645 K090352 000
30884522007560 K090352 000
10884521032491 K090352 000
10884521032514 K090352 000
10884521032521 K090352 000
20884521032535 K090352 000
20884521032542 K090352 000
20884521032559 K090352 000
10884521032569 K090352 000
20884522007532 K090352 000
70884522007575 K090352 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.