ClearanceBrief
Panels › Cardiovascular › Product code NLH · Class 2

Catheter, Recording, Electrode, Reprocessed

Regulation 870.1220

1510(k)s in 12 months (70 all time)
32recalls in 12 months (49 all time)
47recalls that name a 510(k)
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Top companies in NLH

DateFirm and productCodeLinked 510(k)
Oct 5, 2026Stryker Sustainability Solutions
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Open, Classified
NLHK030187
Jul 2, 2026Medline Industries, LP
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical
Open, Classified
NLHK241156
May 13, 2026Stryker Sustainability Solutions
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified
NLHK012708
K030187 +2
Feb 6, 2026Medline Industries, LP
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 40
Open, Classified
NLHK241156
Feb 6, 2026Medline Industries, LP
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter
Open, Classified
NLHK221067
Feb 6, 2026Medline Industries, LP
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-
Open, Classified
NLHK242225
Feb 6, 2026Medline Industries, LP
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer
Open, Classified
NLHK241224
Sep 26, 2025Medline Industries, LP
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH
Open, Classified
NLHK242225
Sep 26, 2025Medline Industries, LP
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
Open, Classified
NLHK241224
Sep 26, 2025Medline Industries, LP
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 40
Open, Classified
NLHK221067
Aug 28, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH,
Open, Classified
NLHK241156
Mar 26, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Open, Classified
NLHK221067
Jul 3, 2024Stryker Sustainability Solutions
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
Open, Classified
NLHK112292
Dec 17, 2018Stryker Sustainability Solutions
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be
Terminated
NLHK112292
Aug 23, 2018Stryker Sustainability Solutions
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Terminated
NLHK112292
Mar 29, 2018Stryker Sustainability Solutions
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrop
Terminated
NLHK100254
Jan 2, 2018Stryker Sustainability Solutions
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters
Terminated
NLHK112292
Jan 2, 2018Stryker Sustainability Solutions
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters
Terminated
NLHK112292
Jan 7, 2017Stryker Sustainability Solutions
Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on th
Terminated
NLHNone listed
Jan 7, 2017Stryker Sustainability Solutions
Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an abla
Terminated
NLHNone listed
Oct 6, 2016Stryker Sustainability Solutions
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (E
Terminated
NLHK012708
K042074
Apr 28, 2016Stryker Sustainability Solutions
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mappi
Terminated
NLHK012708
Nov 18, 2013Stryker Sustainability Solutions
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 4019
Terminated
NLHK012708
K030109 +1
Jan 13, 2009Sterilmed Inc
EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI401915 and EPT7003D Intended for temporary use during electrophysiology studies for intracardiac sensing, reco
Terminated
NLHK012523
K012678 +2

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