Michler-Kapp Cardiovascular Vent Catheter

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Kapp Surgical Instrument, Inc.

The following data is part of a premarket notification filed by Kapp Surgical Instrument, Inc. with the FDA for Michler-kapp Cardiovascular Vent Catheter.

Pre-market Notification Details

Device IDK200289
510k NumberK200289
Device Name:Michler-Kapp Cardiovascular Vent Catheter
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant Kapp Surgical Instrument, Inc. 4919 Warrensville Center Rd Cleveland,  OH  44128
ContactNicole Merrifield
CorrespondentWilliam Mclain
CRO Group, Inc 342 Main Street Leola,  PA  17540
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-05
Decision Date2021-01-28

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