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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 a medical device manufactured by Leadoptik, Inc.. It received FDA 510(k) clearance on 2025-12-19 under approval 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. It is manufactured by Leadoptik, Inc.. The 510(k) number is K251402.

When was LIA-1 Catheter (542-1) approved by the FDA?

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

What company makes LIA-1 Catheter (542-1)?

LIA-1 Catheter (542-1) is manufactured by Leadoptik, Inc..

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 Devices by Leadoptik, Inc.

K251730LIA Console (542-7)

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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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