CARDIOVASCULAR SET UP

Catheter, Intravascular, Diagnostic

MARWOOD MEDICAL, INC.

The following data is part of a premarket notification filed by Marwood Medical, Inc. with the FDA for Cardiovascular Set Up.

Pre-market Notification Details

Device IDK850341
510k NumberK850341
Device Name:CARDIOVASCULAR SET UP
ClassificationCatheter, Intravascular, Diagnostic
Applicant MARWOOD MEDICAL, INC. BOX 8712 Greensboro,  NC  27410
ContactDenise Ranck
CorrespondentDenise Ranck
MARWOOD MEDICAL, INC. BOX 8712 Greensboro,  NC  27410
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-28
Decision Date1985-02-25

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