NUMED BALLOON WEDGE PRESSURE CATHETER

Catheter, Intravascular, Diagnostic

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Balloon Wedge Pressure Catheter.

Pre-market Notification Details

Device IDK864943
510k NumberK864943
Device Name:NUMED BALLOON WEDGE PRESSURE CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant NUMED, INC. MAIN ST. Hopkinton,  NY  12940
ContactAllen J Tower
CorrespondentAllen J Tower
NUMED, INC. MAIN ST. Hopkinton,  NY  12940
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-17
Decision Date1987-02-20

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