Reprocessed PentaRay Nav Eco High-Density Mapping Catheter

Catheter, Intracardiac Mapping, High-density Array

Sterilmed Inc. (Johnson And Johnson)

The following data is part of a premarket notification filed by Sterilmed Inc. (johnson And Johnson) with the FDA for Reprocessed Pentaray Nav Eco High-density Mapping Catheter.

Pre-market Notification Details

Device IDK201806
510k NumberK201806
Device Name:Reprocessed PentaRay Nav Eco High-Density Mapping Catheter
ClassificationCatheter, Intracardiac Mapping, High-density Array
Applicant Sterilmed Inc. (Johnson And Johnson) 5010 Cheshire Parkway N, Suite 2 Plymouth,  MN  55446
ContactJan Flegeau
CorrespondentJan Flegeau
Sterilmed Inc. (Johnson And Johnson) 5010 Cheshire Parkway N, Suite 2 Plymouth,  MN  55446
Product CodeMTD  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-01
Decision Date2021-06-23

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