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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 the device name listed in this FDA 510(k) record. The listed applicant is M/S Meril Life Sciences Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-11-15 under 510(k) 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. The listed applicant is M/S Meril Life Sciences Pvt. , Ltd.. The 510(k) number is K231818.

When did METIC™- Airway Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for METIC™- Airway Balloon Catheter?

The FDA 510(k) record lists M/S Meril Life Sciences Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: KTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation

Official Source

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

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