STREAMLINE VASCULAR ACCESS DEVICE

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 Streamline Vascular Access Device.

Pre-market Notification Details

Device IDK896774
510k NumberK896774
Device Name:STREAMLINE VASCULAR ACCESS DEVICE
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant MENLO CARE, INC. 1053 EAST MEADOW CIRCLE Palo Alto,  CA  94303
ContactColin J Nichols
CorrespondentColin J Nichols
MENLO CARE, INC. 1053 EAST MEADOW CIRCLE Palo Alto,  CA  94303
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-01
Decision Date1989-12-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.