OPTRELL Mapping Catheter With TRUEref Technology

Catheter, Intracardiac Mapping, High-density Array

Biosense Webster, Inc.

The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Optrell Mapping Catheter With Trueref Technology.

Pre-market Notification Details

Device IDK211438
510k NumberK211438
Device Name:OPTRELL Mapping Catheter With TRUEref Technology
ClassificationCatheter, Intracardiac Mapping, High-density Array
Applicant Biosense Webster, Inc. 31 Technology Drive Suite 200 Irvine,  CA  92618
ContactJohn Jimenez
CorrespondentJohn Jimenez
Biosense Webster, Inc. 31 Technology Drive Suite 200 Irvine,  CA  92618
Product CodeMTD  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-10
Decision Date2022-03-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10846835023022 K211438 000
10846835023015 K211438 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.