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)

EUPALAMUS DEFLECTABLE STYLET, MODEL 01545

K-Number: K002534 · 2000-10-18

ApplicantEupalamus, LLC
Decision Date2000-10-18
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 is the device name listed in this FDA 510(k) record. The listed applicant is Eupalamus, LLC. It received FDA 510(k) clearance on 2000-10-18 under 510(k) number K002534. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUPALAMUS DEFLECTABLE STYLET, MODEL 01545?

EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 is a medical device that received FDA 510(k) clearance on 2000-10-18. The listed applicant is Eupalamus, LLC. The 510(k) number is K002534.

When did EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 receive FDA 510(k) clearance?

EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 received FDA 510(k) clearance on 2000-10-18, under 510(k) number K002534.

Who is the listed applicant for EUPALAMUS DEFLECTABLE STYLET, MODEL 01545?

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

What is the FDA product code for EUPALAMUS DEFLECTABLE STYLET, MODEL 01545?

The FDA product code for EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 is DRB.

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: DRB)

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.

K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)K191469Biotronik StyletsBiotronik, Inc.K182660GaltTWSGalt Medical Corp.K170298Liberator Beacon Tip Locking StyletCook IncorporatedK090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078St Jude MedicalK080924MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi

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.

↑