NEW SECOND FRENCH SIZE MAHURKAR CATHETER

Catheter, Femoral

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for New Second French Size Mahurkar Catheter.

Pre-market Notification Details

Device IDK865096
510k NumberK865096
Device Name:NEW SECOND FRENCH SIZE MAHURKAR CATHETER
ClassificationCatheter, Femoral
Applicant QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
ContactMary-lee Donoghue
CorrespondentMary-lee Donoghue
QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
Product CodeLFK  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-30
Decision Date1987-02-18

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