MODIFICATION OF TISSUE DILATOR

Dilator, Vessel, For Percutaneous Catheterization

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modification Of Tissue Dilator.

Pre-market Notification Details

Device IDK862288
510k NumberK862288
Device Name:MODIFICATION OF TISSUE DILATOR
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
ContactDonald L Andersen
CorrespondentDonald L Andersen
QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-16
Decision Date1986-08-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521004006 K862288 000
20884521003993 K862288 000

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