ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB

Catheter, Percutaneous

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Envoy Distal Access (da) Guiding Catheter, 6f, 95cm & 105cm, Straight & Xb, Mpd & Xb, Mpc & Xb.

Pre-market Notification Details

Device IDK140080
510k NumberK140080
Device Name:ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
ClassificationCatheter, Percutaneous
Applicant Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactHannah Foley
CorrespondentHannah Foley
Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-14
Decision Date2014-04-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704075127 K140080 000
10878528000652 K140080 000
10878528000669 K140080 000
10878528000676 K140080 000
10886704074816 K140080 000
10886704075066 K140080 000
10886704075073 K140080 000
10886704075080 K140080 000
10886704075097 K140080 000
10886704075103 K140080 000
10886704075110 K140080 000
10878528000645 K140080 000

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