FDA 510(k)

MEDCOMP VASCU-PICC WITH VALVE

K-Number: K130897 · 2013-10-22

Decision Date2013-10-22

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MEDCOMP VASCU-PICC WITH VALVE 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 2013-10-22 under 510(k) number K130897. 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 MEDCOMP VASCU-PICC WITH VALVE?

MEDCOMP VASCU-PICC WITH VALVE is a medical device that received FDA 510(k) clearance on 2013-10-22. The listed applicant is Medcomp ( Medical Components). The 510(k) number is K130897.

When did MEDCOMP VASCU-PICC WITH VALVE receive FDA 510(k) clearance?

MEDCOMP VASCU-PICC WITH VALVE received FDA 510(k) clearance on 2013-10-22, under 510(k) number K130897.

Who is the listed applicant for MEDCOMP VASCU-PICC WITH VALVE?

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 MEDCOMP VASCU-PICC WITH VALVE?

The FDA product code for MEDCOMP VASCU-PICC WITH VALVE is LJS.

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Other records listing Medcomp ( Medical Components) as applicant

K162389Medcomp Vessel Dilator K153238Dignity Dual Port K132177MEDCOMP GEN III POWER INJECTABLE PORT K110424DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL K093309PRO-LINE CT (BASIC TRAY) MODEL MR28036101

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.