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FDA 510(k)

SLIM Microcatheter

K-Number: K260199 · 2026-07-13

ApplicantBalt USA, LLC
Decision Date2026-07-13
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SLIM Microcatheter 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 2026-07-13 under 510(k) number K260199. 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 SLIM Microcatheter?

SLIM Microcatheter is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is Balt USA, LLC. The 510(k) number is K260199.

When did SLIM Microcatheter receive FDA 510(k) clearance?

SLIM Microcatheter received FDA 510(k) clearance on 2026-07-13, under 510(k) number K260199.

Who is the listed applicant for SLIM Microcatheter?

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 SLIM Microcatheter?

The FDA product code for SLIM Microcatheter is QJP.

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Other records listing Balt USA, LLC as applicant

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.

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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.

K253901Millipede88 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 LimitedK254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.

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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