FDA 510(k)

PRO-LINE CT (BASIC TRAY) MODEL MR28036101

K-Number: K093309 · 2009-11-24

Decision Date2009-11-24

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRO-LINE CT (BASIC TRAY) MODEL MR28036101 is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp ( Medical Components). It received FDA 510(k) clearance on 2009-11-24 under 510(k) number K093309. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-LINE CT (BASIC TRAY) MODEL MR28036101?

PRO-LINE CT (BASIC TRAY) MODEL MR28036101 is a medical device that received FDA 510(k) clearance on 2009-11-24. The listed applicant is Medcomp ( Medical Components). The 510(k) number is K093309.

When did PRO-LINE CT (BASIC TRAY) MODEL MR28036101 receive FDA 510(k) clearance?

PRO-LINE CT (BASIC TRAY) MODEL MR28036101 received FDA 510(k) clearance on 2009-11-24, under 510(k) number K093309.

Who is the listed applicant for PRO-LINE CT (BASIC TRAY) MODEL MR28036101?

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

What is the FDA product code for PRO-LINE CT (BASIC TRAY) MODEL MR28036101?

The FDA product code for PRO-LINE CT (BASIC TRAY) MODEL MR28036101 is LJS.

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

Other records listing Medcomp ( Medical Components) as applicant

K162389Medcomp Vessel Dilator K153238Dignity Dual Port K132177MEDCOMP GEN III POWER INJECTABLE PORT K130897MEDCOMP VASCU-PICC WITH VALVE K110424DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL

Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum Vascular K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, 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.