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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 a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2024-07-02 under approval 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. It is manufactured by Balt USA, LLC. The 510(k) number is K234074.

When was Next Generation Access Catheter approved by the FDA?

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

What company makes Next Generation Access Catheter?

Next Generation Access Catheter is manufactured by Balt USA, LLC.

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

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING NCT04498598 Structural Modification In Supraglottic Airway Device RECRUITING NCT06281730 Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy ENROLLING_BY_INVITATION NCT02633124 Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants. TERMINATED

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Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, Inc.

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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