ClearanceBrief
510(k) K120425 ยท MTD Catheter, Intracardiac Mapping, High-Density Array

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER

ApplicantBiosense Webster, Inc., Diamond Bar CA, US
DecisionSubstantially Equivalent, May 24, 2012
ReceivedFeb 13, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K120425

DateFirm and productCodeLinked 510(k)
Apr 22, 2020BIOSENSE WEBSTER
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode
Terminated		 MTDNone listed
May 17, 2017Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter.
Terminated		 MTDNone listed
May 17, 2017Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter.
Terminated		 MTDNone listed
Apr 14, 2016Biosense Webster, Inc.
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple e
Terminated		 MTDNone listed
Mar 11, 2014Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-De
Terminated		 MTDNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.