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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 6 of 6 Results
ProductCode: MTD Applicant: BIOSENSE WEBSTER, INC. Decision Date To: 06/07/2024
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optrell™ mapping catheter with trueref™ technology Biosense Webster, Inc. K230253 03/02/2023
optrell mapping catheter with trueref technology Biosense Webster, Inc. K211438 03/18/2022
carto octaray mapping catheter with trueref technology Biosense Webster, Inc. K193237 07/31/2020
pentaray nav eco high-density mapping catheter BIOSENSE WEBSTER, INC. K123837 03/05/2013
pentaray nav high-density mapping catheter BIOSENSE WEBSTER, INC. K120425 05/24/2012
flower high-density mapping catheter, 4-4-4 mm electrode spacing), (2-6-2 mm electrode spacing) BIOSENSE WEBSTER, INC. K050217 03/30/2005
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