2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC

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

MEDCOMP

The following data is part of a premarket notification filed by Medcomp with the FDA for 2.6f X 20cm Vascu-picc, 2.6f X 50cm Vascu-picc.

Pre-market Notification Details

Device IDK102966
510k NumberK102966
Device Name:2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant MEDCOMP 1499 DELP DR. Harleysville,  PA  19438
ContactJean Callow
CorrespondentJean Callow
MEDCOMP 1499 DELP DR. Harleysville,  PA  19438
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-05
Decision Date2010-12-21
Summary:summary

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