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)

H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG

K-Number: K874508 · 1988-01-19

ApplicantHolter-Hausner Intl.
Decision Date1988-01-19
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG is the device name listed in this FDA 510(k) record. The listed applicant is Holter-Hausner Intl.. It received FDA 510(k) clearance on 1988-01-19 under 510(k) number K874508. 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 H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG?

H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG is a medical device that received FDA 510(k) clearance on 1988-01-19. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K874508.

When did H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG receive FDA 510(k) clearance?

H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG received FDA 510(k) clearance on 1988-01-19, under 510(k) number K874508.

Who is the listed applicant for H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG?

The FDA 510(k) record lists Holter-Hausner Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG?

The FDA product code for H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG 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 Holter-Hausner Intl. 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.

K875287H-H FLUSHING RESERVOIRK872293H-H HUNTER ACTIVE TENDON IMPLANT BCK872284H-H HUNTER ACTIVE TENDON IMPLANT PCK872285H-H HUNTER ACTIVE TENDON IMPLANT DCK871351H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAPK870660H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS

View all 42 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.

↑