MODIFIED QUINTON SINGLE LUMEN CATHETER

Catheter, Hemodialysis, Non-implanted

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Quinton Single Lumen Catheter.

Pre-market Notification Details

Device IDK896252
510k NumberK896252
Device Name:MODIFIED QUINTON SINGLE LUMEN CATHETER
ClassificationCatheter, Hemodialysis, Non-implanted
Applicant QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell,  WA  98021 -8906
ContactRandy Walls
CorrespondentRandy Walls
QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell,  WA  98021 -8906
Product CodeMPB  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-30
Decision Date1990-01-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521794754 K896252 000
20884521794747 K896252 000
20884521794730 K896252 000
20884521056746 K896252 000
20884521056760 K896252 000

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