MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER

Catheter, Flow Directed

NUMED, INC.

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

Pre-market Notification Details

Device IDK883948
510k NumberK883948
Device Name:MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER
ClassificationCatheter, Flow Directed
Applicant NUMED, INC. MAIN ST. Hopkinton,  NY  12940
ContactAllen J Tower
CorrespondentAllen J Tower
NUMED, INC. MAIN ST. Hopkinton,  NY  12940
Product CodeDYG  
CFR Regulation Number870.1240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-13
Decision Date1989-04-21

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