Classic ERCP Catheter And Huibregtse-Katon ERCP Catheter And Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & W/ Radiopaque Bands, Fusion ERCP Catheter With DomeTip And Fusion OMNI ERCP Catheter With DomeTip, Ha

Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula

Wilson-Cook Medical Inc.

The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for Classic Ercp Catheter And Huibregtse-katon Ercp Catheter And Huibregtse-katon Angled, Glo-tip Ercp Catheter, Glo-tip Ii Double Lumen Ercp Catheter & W/ Radiopaque Bands, Fusion Ercp Catheter With Dometip And Fusion Omni Ercp Catheter With Dometip, Ha.

Pre-market Notification Details

Device IDK171989
510k NumberK171989
Device Name:Classic ERCP Catheter And Huibregtse-Katon ERCP Catheter And Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & W/ Radiopaque Bands, Fusion ERCP Catheter With DomeTip And Fusion OMNI ERCP Catheter With DomeTip, Ha
ClassificationEndoscopic Retrograde Cholangiopancreatography (ercp) Cannula
Applicant Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-salem,  NC  27105
ContactAshley Howard
CorrespondentAshley Howard
Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-salem,  NC  27105
Product CodeODD  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-03
Decision Date2018-03-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00827002572881 K171989 000
00827002572850 K171989 000
00827002572898 K171989 000

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