MEDCOMP VASCU-PICC WITH VALVE

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

MEDCOMP (MEDICAL COMPONENTS)

The following data is part of a premarket notification filed by Medcomp (medical Components) with the FDA for Medcomp Vascu-picc With Valve.

Pre-market Notification Details

Device IDK130897
510k NumberK130897
Device Name:MEDCOMP VASCU-PICC WITH VALVE
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville,  PA  19438
ContactJessica Leo
CorrespondentJessica Leo
MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville,  PA  19438
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-01
Decision Date2013-10-22
Summary:summary

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