VisionAir Patient-Specific Airway Stent

Prosthesis, Tracheal, Preformed/molded

New COS Inc. DBA VisionAir Solutions

The following data is part of a premarket notification filed by New Cos Inc. Dba Visionair Solutions with the FDA for Visionair Patient-specific Airway Stent.

Pre-market Notification Details

Device IDK213969
510k NumberK213969
Device Name:VisionAir Patient-Specific Airway Stent
ClassificationProsthesis, Tracheal, Preformed/molded
Applicant New COS Inc. DBA VisionAir Solutions 7100 Euclid Ave, Ste 180 Cleveland,  OH  44103
ContactKeith Grafmeyer
CorrespondentKeith Grafmeyer
New COS Inc. DBA VisionAir Solutions 7100 Euclid Ave, Ste 180 Cleveland,  OH  44103
Product CodeNWA  
CFR Regulation Number878.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-20
Decision Date2022-10-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860011822608 K213969 000

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