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

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

MEDICAL COMPONENTS INC

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

Pre-market Notification Details

Device IDK120981
510k NumberK120981
Device Name:2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville,  PA  19438
ContactJean Callow
CorrespondentJean Callow
MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville,  PA  19438
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-02
Decision Date2012-05-02

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