SAFE-PICC CATHETER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

MENLO CARE, INC.

The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Safe-picc Catheter.

Pre-market Notification Details

Device IDK930048
510k NumberK930048
Device Name:SAFE-PICC CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant MENLO CARE, INC. 1350 WILLOW RD. Menlo Park,  CA  94025 -1516
ContactThomas Lawson
CorrespondentThomas Lawson
MENLO CARE, INC. 1350 WILLOW RD. Menlo Park,  CA  94025 -1516
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-05
Decision Date1994-05-12

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