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)

SoloPath Re-Collapsible Access System

K-Number: K152498 · 2016-01-05

ApplicantOnset Medical Corporation
Decision Date2016-01-05
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SoloPath Re-Collapsible Access System is a medical device manufactured by Onset Medical Corporation. It received FDA 510(k) clearance on 2016-01-05 under approval number K152498. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SoloPath Re-Collapsible Access System?

SoloPath Re-Collapsible Access System is a medical device that received FDA 510(k) clearance on 2016-01-05. It is manufactured by Onset Medical Corporation. The 510(k) number is K152498.

When was SoloPath Re-Collapsible Access System approved by the FDA?

SoloPath Re-Collapsible Access System received FDA 510(k) clearance on 2016-01-05, under approval number K152498.

What company makes SoloPath Re-Collapsible Access System?

SoloPath Re-Collapsible Access System is manufactured by Onset Medical Corporation.

What is the FDA product code for SoloPath Re-Collapsible Access System?

The FDA product code for SoloPath Re-Collapsible Access System is DYB.

Related Clinical Trials

NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT05934487 PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III RECRUITING NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT07110337 Diagnosing Epilepsy To EffeCT Change RECRUITING NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING NCT07586098 AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025) PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023) PMID: 36476364 ScanMedicine: An online search system for medical innovation. Contemporary clinical trials (2023) PMID: 29988408 Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke. Frontiers in neurology (2018)

Related Devices (Code: DYB)

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC K162097InTRAkitMedtronic Vascular K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. K153771TXM Guiding SheathTexasmedical Technologies, Inc. K162184Edwards eSheath Introducer SetEdward Lifesciences K153494HQS Introducer (Model 2064-HQS)Alseal

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.

↑