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Panels › Cardiovascular › Product code MTD · Class 2

Catheter, Intracardiac Mapping, High-Density Array

Regulation 870.1220

2510(k)s in 12 months (34 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
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Top companies in MTD

Company510(k)sRecalls
Biosense Webster, Inc.86
Boston Scientific Corp61
Abbott Electrophysiology21
Acutus Medical, Inc.30
Cardiac Pathways Corp.20
Cortex, Inc.20
Endocardial Solutions, Inc.20
St Jude Medical20
Topera, Inc.20
Abbott01
DateFirm and productCodeLinked 510(k)
Apr 28, 2022Abbott
FIRMap" Catheter, 60mm Basket
Terminated		 MTDK142182
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		 MTDK120425
May 17, 2017Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter.
Terminated		 MTDK120425
K123837
May 17, 2017Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter.
Terminated		 MTDK120425
K123837
Apr 14, 2016Biosense Webster, Inc.
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multip
Terminated		 MTDK123837
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		 MTDK120425
Aug 28, 2015Abbott Electrophysiology
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures t
Terminated		 MTDK130827
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		 MTDK120425
K123837
Mar 18, 2005Boston Scientific
Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
Terminated		 MTDK000277
K003782 +3

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