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)

Next Generation Access Catheter

K-Number: K234074 · 2024-07-02

ApplicantBalt USA, LLC
Decision Date2024-07-02
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Next Generation Access 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 2024-07-02 under 510(k) number K234074. 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 Catheter?

Next Generation Access Catheter is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Balt USA, LLC. The 510(k) number is K234074.

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

Next Generation Access Catheter received FDA 510(k) clearance on 2024-07-02, under 510(k) number K234074.

Who is the listed applicant for Next Generation Access 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 Access Catheter?

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

Related Clinical Trials

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.

NCT04410146The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)COMPLETEDNCT07225075Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)RECRUITINGNCT07585188Neonatal Catheter Lock for Infection PreventionNOT_YET_RECRUITING

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 MicrocatheterK254223Next Generation 088 CatheterPMA P250009Neurovascular Liquid Embolic AgentK254221Optima Coil System (OptiOne Coil System)K252569Carrier XL Delivery CatheterK252700Optima Coil System (Optima Packing Coil System)

View all 20 devices →

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.

↑