FDA 510(k)

PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES

K-Number: K041345 · 2004-07-22

Decision Date2004-07-22

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Medix, Inc.. It received FDA 510(k) clearance on 2004-07-22 under 510(k) number K041345. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES?

PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES is a medical device that received FDA 510(k) clearance on 2004-07-22. The listed applicant is Medix, Inc.. The 510(k) number is K041345.

When did PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES receive FDA 510(k) clearance?

PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES received FDA 510(k) clearance on 2004-07-22, under 510(k) number K041345.

Who is the listed applicant for PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES?

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

What is the FDA product code for PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES?

The FDA product code for PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES is FOZ.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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.