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FDA 510(k)

SurfRider 13 Microcatheter

K-Number: K251668 · 2026-01-05

ApplicantKaneka Americas Holding, Inc.
Decision Date2026-01-05
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SurfRider 13 Microcatheter is a medical device manufactured by Kaneka Americas Holding, Inc.. It received FDA 510(k) clearance on 2026-01-05 under approval number K251668. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurfRider 13 Microcatheter?

SurfRider 13 Microcatheter is a medical device that received FDA 510(k) clearance on 2026-01-05. It is manufactured by Kaneka Americas Holding, Inc.. The 510(k) number is K251668.

When was SurfRider 13 Microcatheter approved by the FDA?

SurfRider 13 Microcatheter received FDA 510(k) clearance on 2026-01-05, under approval number K251668.

What company makes SurfRider 13 Microcatheter?

SurfRider 13 Microcatheter is manufactured by Kaneka Americas Holding, Inc..

What is the FDA product code for SurfRider 13 Microcatheter?

The FDA product code for SurfRider 13 Microcatheter is QJP.

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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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