Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

METIC™- Airway Balloon Catheter

K-Number: K231818 · 2023-11-15

ApplicantM/S Meril Life Sciences Pvt. , Ltd.
Decision Date2023-11-15
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

METIC™- Airway Balloon Catheter is a medical device manufactured by M/S Meril Life Sciences Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-11-15 under approval number K231818. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METIC™- Airway Balloon Catheter?

METIC™- Airway Balloon Catheter is a medical device that received FDA 510(k) clearance on 2023-11-15. It is manufactured by M/S Meril Life Sciences Pvt. , Ltd.. The 510(k) number is K231818.

When was METIC™- Airway Balloon Catheter approved by the FDA?

METIC™- Airway Balloon Catheter received FDA 510(k) clearance on 2023-11-15, under approval number K231818.

What company makes METIC™- Airway Balloon Catheter?

METIC™- Airway Balloon Catheter is manufactured by M/S Meril Life Sciences Pvt. , Ltd..

What is the FDA product code for METIC™- Airway Balloon Catheter?

The FDA product code for METIC™- Airway Balloon Catheter is KTI.

Related Clinical Trials

NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter NOT_YET_RECRUITING NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING

Related Devices (Code: KTI)

K161392Elation Pulmonary Balloon DilationMerit Medical Systems, Inc. K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC K152922ViziShot FLEXSpiration, Inc. K171232PeriView FLEXOlympus Surgical Technologies America K170759CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation K163469ViziShot 2 FLEXOlympus Surgical Technologies America

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑