SAFE-CATH

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

SCIENTIFIC DEVICE MANUFACTURER LLC.

The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Safe-cath.

Pre-market Notification Details

Device IDK960764
510k NumberK960764
Device Name:SAFE-CATH
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael,  CA  94901
ContactRichard C Bell
CorrespondentRichard C Bell
SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael,  CA  94901
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-26
Decision Date1997-04-24
Summary:summary

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