DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE

Tube, Tracheal (w/wo Connector)

SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Dic Tracheostomy Tube And Portex Blue Line.

Pre-market Notification Details

Device IDK934465
510k NumberK934465
Device Name:DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
ClassificationTube, Tracheal (w/wo Connector)
Applicant SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene,  NH  03431
ContactTimothy J Talcott
CorrespondentTimothy J Talcott
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene,  NH  03431
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-13
Decision Date1994-01-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10351688036933 K934465 000
10351688000231 K934465 000
10351688000644 K934465 000
10351688001481 K934465 000
10351688006677 K934465 000
10351688009265 K934465 000
10351688010339 K934465 000
10351688017772 K934465 000
10351688021007 K934465 000
10351688022066 K934465 000
10351688023544 K934465 000
10351688024923 K934465 000
10351688027900 K934465 000
10351688033161 K934465 000
10351688036117 K934465 000
10351688018243 K934465 000

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