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)

EXPLORER LIVER (PASSIVE TRACKING)

K-Number: K101979 · 2011-02-09

ApplicantPathfinder Therapeutics, Inc.
Decision Date2011-02-09
Product CodeOEW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EXPLORER LIVER (PASSIVE TRACKING) is the device name listed in this FDA 510(k) record. The listed applicant is Pathfinder Therapeutics, Inc.. It received FDA 510(k) clearance on 2011-02-09 under 510(k) number K101979. The device is classified under product code OEW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPLORER LIVER (PASSIVE TRACKING)?

EXPLORER LIVER (PASSIVE TRACKING) is a medical device that received FDA 510(k) clearance on 2011-02-09. The listed applicant is Pathfinder Therapeutics, Inc.. The 510(k) number is K101979.

When did EXPLORER LIVER (PASSIVE TRACKING) receive FDA 510(k) clearance?

EXPLORER LIVER (PASSIVE TRACKING) received FDA 510(k) clearance on 2011-02-09, under 510(k) number K101979.

Who is the listed applicant for EXPLORER LIVER (PASSIVE TRACKING)?

The FDA 510(k) record lists Pathfinder Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPLORER LIVER (PASSIVE TRACKING)?

The FDA product code for EXPLORER LIVER (PASSIVE TRACKING) is OEW.

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 Pathfinder Therapeutics, Inc. 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.

K093494LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEMK082228PLANISIGHT LINASYSK071063LINASYS

Related Devices (Code: OEW)

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.

K093494LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEMPathfinder Therapeutics, Inc.K071063LINASYSPathfinder Therapeutics, 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.

↑