FDA 510(k)

SurfRider 13 Microcatheter

K-Nummer: K251668 · 2026-01-05

AntragstellerKaneka Americas Holding, Inc.

Entscheidungsdatum2026-01-05

ProduktcodeQJP

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

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

Häufig gestellte Fragen

What is the SurfRider 13 Microcatheter?

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

When did SurfRider 13 Microcatheter receive FDA 510(k) clearance?

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

Who is the listed applicant for SurfRider 13 Microcatheter?

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

What is the FDA product code for SurfRider 13 Microcatheter?

The FDA product code for SurfRider 13 Microcatheter is QJP.

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Verwandte Geräte (Code: QJP)

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