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FDA 510(k)

Next Generation Access Platform

K-Number: K242376 · 2024-12-30

ApplicantBalt USA, LLC
Decision Date2024-12-30
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Next Generation Access Platform is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2024-12-30 under 510(k) number K242376. 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 Next Generation Access Platform?

Next Generation Access Platform is a medical device that received FDA 510(k) clearance on 2024-12-30. The listed applicant is Balt USA, LLC. The 510(k) number is K242376.

When did Next Generation Access Platform receive FDA 510(k) clearance?

Next Generation Access Platform received FDA 510(k) clearance on 2024-12-30, under 510(k) number K242376.

Who is the listed applicant for Next Generation Access Platform?

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

What is the FDA product code for Next Generation Access Platform?

The FDA product code for Next Generation Access Platform is QJP.

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Other records listing Balt USA, LLC as applicant

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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.

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