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)

PS MEDICAL STRATA II VALVE

K-Number: K042465 · 2004-10-19

ApplicantMedtronic Neurosurgery
Decision Date2004-10-19
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PS MEDICAL STRATA II VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2004-10-19 under 510(k) number K042465. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PS MEDICAL STRATA II VALVE?

PS MEDICAL STRATA II VALVE is a medical device that received FDA 510(k) clearance on 2004-10-19. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K042465.

When did PS MEDICAL STRATA II VALVE receive FDA 510(k) clearance?

PS MEDICAL STRATA II VALVE received FDA 510(k) clearance on 2004-10-19, under 510(k) number K042465.

Who is the listed applicant for PS MEDICAL STRATA II VALVE?

The FDA 510(k) record lists Medtronic Neurosurgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PS MEDICAL STRATA II VALVE?

The FDA product code for PS MEDICAL STRATA II VALVE is JXG.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medtronic Neurosurgery 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.

K243676Duet External Drainage and Monitoring System (EDMS)K242034Duet External Drainage and Monitoring System (EDMS)K212641StrataMR II Valves and ShuntsK181622StrataMR guider toolK161370Durepair Dura Regeneration MatrixK152700StrataMR Valves and Shunts

View all 27 devices →

Related Devices (Code: JXG)

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.

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

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.

↑