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FDA 510(k)

Next Generation 088 Catheter

K-Number: K254223 · 2026-04-16

ApplicantBalt USA, LLC
Decision Date2026-04-16
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Next Generation 088 Catheter 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 2026-04-16 under 510(k) number K254223. 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 088 Catheter?

Next Generation 088 Catheter is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Balt USA, LLC. The 510(k) number is K254223.

When did Next Generation 088 Catheter receive FDA 510(k) clearance?

Next Generation 088 Catheter received FDA 510(k) clearance on 2026-04-16, under 510(k) number K254223.

Who is the listed applicant for Next Generation 088 Catheter?

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 088 Catheter?

The FDA product code for Next Generation 088 Catheter 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.

K260199SLIM MicrocatheterPMA P250009Neurovascular Liquid Embolic AgentK254221Optima Coil System (OptiOne Coil System)K252569Carrier XL Delivery CatheterK252700Optima Coil System (Optima Packing Coil System)K243948Raptor Aspiration Catheter; Balt Aspiration Tubing Set

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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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