PERM-CATH CATHETER KIT

Catheter, Subclavian

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Perm-cath Catheter Kit.

Pre-market Notification Details

Device IDK871942
510k NumberK871942
Device Name:PERM-CATH CATHETER KIT
ClassificationCatheter, Subclavian
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 CodeLFJ  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-19
Decision Date1987-06-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521009902 K871942 000
20884521009872 K871942 000
10884521009882 K871942 000
10884521009868 K871942 000

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