MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Rt. Artrial And 13.5x11.5f Cath. Tray.

Pre-market Notification Details

Device IDK885188
510k NumberK885188
Device Name:MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
ContactRon R Duck
CorrespondentRon R Duck
QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-07
Decision Date1989-02-06

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