FDA 510(k)

PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM

K-Number: K091312 · 2009-09-02

Decision Date2009-09-02

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2009-09-02 under 510(k) number K091312. 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 NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM?

PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-02. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K091312.

When did PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM receive FDA 510(k) clearance?

PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM received FDA 510(k) clearance on 2009-09-02, under 510(k) number K091312.

Who is the listed applicant for PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM?

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 NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM?

The FDA product code for PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medtronic Neurosurgery as applicant

K243676Duet External Drainage and Monitoring System (EDMS)K242034Duet External Drainage and Monitoring System (EDMS)K212641StrataMR II Valves and Shunts K181622StrataMR guider tool K161370Durepair Dura Regeneration Matrix K152700StrataMR Valves and Shunts

View all 27 devices →

Related Devices (Code: JXG)

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation K243552Codman 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.