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)

THE PATHFINDER SYSTEM

K-Number: K890483 · 1989-03-14

ApplicantDenmark Assoc.
Decision Date1989-03-14
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE PATHFINDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Denmark Assoc.. It received FDA 510(k) clearance on 1989-03-14 under 510(k) number K890483. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE PATHFINDER SYSTEM?

THE PATHFINDER SYSTEM is a medical device that received FDA 510(k) clearance on 1989-03-14. The listed applicant is Denmark Assoc.. The 510(k) number is K890483.

When did THE PATHFINDER SYSTEM receive FDA 510(k) clearance?

THE PATHFINDER SYSTEM received FDA 510(k) clearance on 1989-03-14, under 510(k) number K890483.

Who is the listed applicant for THE PATHFINDER SYSTEM?

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

What is the FDA product code for THE PATHFINDER SYSTEM?

The FDA product code for THE PATHFINDER SYSTEM is IZH.

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

Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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.

↑