CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...

Catheter, Hemodialysis, Implanted

Teleflex Medical, Inc.

The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Cannon Ii Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter, Nextstep(r) Retrograde Chronic....

Pre-market Notification Details

Device IDK111117
510k NumberK111117
Device Name:CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...
ClassificationCatheter, Hemodialysis, Implanted
Applicant Teleflex Medical, Inc. 2400 BERNVILLE ROAD Reading,  PA  19605
ContactSuzanne Schorle
CorrespondentSuzanne Schorle
Teleflex Medical, Inc. 2400 BERNVILLE ROAD Reading,  PA  19605
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-21
Decision Date2011-06-30

NIH GUDID Devices

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