ENVOY GUIDING CATHETER

Catheter, Percutaneous

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Envoy Guiding Catheter.

Pre-market Notification Details

Device IDK140307
510k NumberK140307
Device Name:ENVOY GUIDING CATHETER
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 Received2014-02-07
Decision Date2014-04-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704075042 K140307 000
10886704075028 K140307 000
10886704075011 K140307 000
10886704074991 K140307 000
10886704074977 K140307 000
10886704074953 K140307 000
10886704074939 K140307 000
10886704074908 K140307 000
10886704074878 K140307 000
10886704074854 K140307 000
10886704075059 K140307 000
10886704074823 K140307 000
10886704074847 K140307 000
10886704075035 K140307 000
10886704075004 K140307 000
10886704074984 K140307 000
10886704074960 K140307 000
10886704074946 K140307 000
10886704074922 K140307 000
10886704074915 K140307 000
10886704074885 K140307 000
10886704074861 K140307 000
10886704074830 K140307 000

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