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FDA 510(k)

LIA-1 Catheter (542-1)

K-Number: K251402 · 2025-12-19

ApplicantLeadoptik, Inc.
Decision Date2025-12-19
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LIA-1 Catheter (542-1) is the device name listed in this FDA 510(k) record. The listed applicant is Leadoptik, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251402. 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 LIA-1 Catheter (542-1)?

LIA-1 Catheter (542-1) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Leadoptik, Inc.. The 510(k) number is K251402.

When did LIA-1 Catheter (542-1) receive FDA 510(k) clearance?

LIA-1 Catheter (542-1) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251402.

Who is the listed applicant for LIA-1 Catheter (542-1)?

The FDA 510(k) record lists Leadoptik, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIA-1 Catheter (542-1)?

The FDA product code for LIA-1 Catheter (542-1) is KTI.

Other records listing Leadoptik, Inc. as applicant

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.

K251730LIA Console (542-7)

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.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 CorporationK250263Disposable Grasping Forceps FG-52D/FG-54DOlympus Medical Systems Corp.

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.

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