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510(k) Data Aggregation
K Number
K231818Device Name
METIC- Airway Balloon Catheter
Manufacturer
M/s Meril Life Sciences Pvt. Ltd.
Date Cleared
2023-11-15
(147 days)
Product Code
KTI
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
M/s Meril Life Sciences Pvt. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
METIC™ – Airway Balloon Catheter is intended to dilate strictures of the airway.
Device Description
The METIC™ – Airway Balloon Catheter is comprised of a single lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A Luer at the proximal end is used for the placement of the stylet and injecting sterile water into the balloon.
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