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)
Top companies in NLH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2026 | Stryker Sustainability Solutions BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007 Open, Classified |
NLH | K030187 |
| Jul 2, 2026 | Medline 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 |
NLH | K241156 |
| May 13, 2026 | Stryker Sustainability Solutions Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic Tip Steerable, Product Number 6DYNTP001; Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| May 13, 2026 | Stryker Sustainability Solutions BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER Open, Classified |
NLH | K012708 K030187 +2 |
| Feb 6, 2026 | Medline 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 |
NLH | K241156 |
| Feb 6, 2026 | Medline 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 |
NLH | K221067 |
| Feb 6, 2026 | Medline 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 |
NLH | K242225 |
| Feb 6, 2026 | Medline 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 |
NLH | K241224 |
| Sep 26, 2025 | Medline 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 |
NLH | K242225 |
| Sep 26, 2025 | Medline Industries, LP Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH Open, Classified |
NLH | K241224 |
| Sep 26, 2025 | Medline 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 |
NLH | K221067 |
| Aug 28, 2025 | MEDLINE 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 |
NLH | K241156 |
| Mar 26, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R Open, Classified |
NLH | K221067 |
| Jul 3, 2024 | Stryker 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 |
NLH | K112292 |
| Dec 17, 2018 | Stryker 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 |
NLH | K112292 |
| Aug 23, 2018 | Stryker 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 |
NLH | K112292 |
| Mar 29, 2018 | Stryker 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 |
NLH | K100254 |
| Jan 2, 2018 | Stryker 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 |
NLH | K112292 |
| Jan 2, 2018 | Stryker 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 |
NLH | K112292 |
| Jan 7, 2017 | Stryker 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 |
NLH | None listed |
| Jan 7, 2017 | Stryker 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 |
NLH | None listed |
| Oct 6, 2016 | Stryker 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 |
NLH | K012708 K042074 |
| Apr 28, 2016 | Stryker Sustainability Solutions Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mappi Terminated |
NLH | K012708 |
| Nov 18, 2013 | Stryker 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 |
NLH | K012708 K030109 +1 |
| Jan 13, 2009 | Sterilmed 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 |
NLH | K012523 K012678 +2 |
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