Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

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. 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.

Related Devices (Code: QJP)

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.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

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.

↑