METIC- Airway Balloon Catheter— 510(k) K231818

Substantially Equivalent

M/S Meril Life Sciences Pvt. , Ltd.

FDA 510(k) clearance K231818 for METIC- Airway Balloon Catheter, Substantially Equivalent on 2023-11-15. Applicant: M/S Meril Life Sciences Pvt. , Ltd..

Clearance details

Applicant: M/S Meril Life Sciences Pvt. , Ltd.
Product code: Code KTI
Advisory panel: Ear, Nose, Throat
Date received: 2023-06-21
Decision date: 2023-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vapi, IN

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.