Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2024-12-30 under approval 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. It is manufactured by Balt USA, LLC. The 510(k) number is K242376.

When was Next Generation Access Platform approved by the FDA?

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

What company makes Next Generation Access Platform?

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

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

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

Related Clinical Trials

NCT07587593 The IVCare Adaptive Platform Trial NOT_YET_RECRUITING NCT07578454 VRehab-SMA Phase 1.2 NOT_YET_RECRUITING NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT02603640 " Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy COMPLETED NCT06647576 Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs COMPLETED NCT07573098 Digital Tool for Improved Self-management of COPD RECRUITING

Related PubMed Literature

PMID: 41790854 A Substance Use Disorder Virtual Treatment and Research Platform: A Proof of Concept. IEEE pulse (2025)

Other Devices by Balt USA, LLC

K182337HYBRID Guidewire K183045Eclipse 2L K182918Ballast 088 Long Sheath K200030Optima Coil System K202366MAGIC Infusion Catheter K223386Optima Coil System

View all 19 devices →

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.

↑