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)

ENDOSCOPIC VENTRICULAR CATHETER

K-Number: K971617 · 1997-07-31

ApplicantIntegra Neurocare, LLC
Decision Date1997-07-31
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC VENTRICULAR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurocare, LLC. It received FDA 510(k) clearance on 1997-07-31 under 510(k) number K971617. 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 ENDOSCOPIC VENTRICULAR CATHETER?

ENDOSCOPIC VENTRICULAR CATHETER is a medical device that received FDA 510(k) clearance on 1997-07-31. The listed applicant is Integra Neurocare, LLC. The 510(k) number is K971617.

When did ENDOSCOPIC VENTRICULAR CATHETER receive FDA 510(k) clearance?

ENDOSCOPIC VENTRICULAR CATHETER received FDA 510(k) clearance on 1997-07-31, under 510(k) number K971617.

Who is the listed applicant for ENDOSCOPIC VENTRICULAR CATHETER?

The FDA 510(k) record lists Integra Neurocare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPIC VENTRICULAR CATHETER?

The FDA product code for ENDOSCOPIC VENTRICULAR CATHETER 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 Integra Neurocare, LLC 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.

K002392VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-VK992006NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33K981246BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)K973525MAURICE WORLDWIDE SHUNT SYSTEMK972994EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMSK972261RIVETTI-LEVINSON INSTRALUMINAL SHUNT

View all 12 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.

↑