KELLY INFLATABLE T DRAIN

Stents, Drains And Dilators For The Biliary Ducts

AKRON CATHETER, INC.

The following data is part of a premarket notification filed by Akron Catheter, Inc. with the FDA for Kelly Inflatable T Drain.

Pre-market Notification Details

Device IDK823428
510k NumberK823428
Device Name:KELLY INFLATABLE T DRAIN
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant AKRON CATHETER, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-16
Decision Date1983-01-18

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