Product Code: NLH FDA class 2 21 CFR 870.1220

Catheter, Recording, Electrode, Reprocessed

Cardiovascular

The Reprocessed Recording Electrode Catheter is a reprocessed cardiovascular electrophysiology device used to record intracardiac electrical signals during diagnostic electrophysiology studies; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLH and regulation 21 CFR 870.1220 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.

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FEI Numbers

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Basic Information

Product Code: NLH
Device Class: FDA class 2
Regulation Number: 870.1220
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 70 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252405	Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter	Nov 26, 2025	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K250772	Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter	Jul 11, 2025	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K242225	Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter	Nov 29, 2024	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K241224	Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)	Nov 15, 2024	Substantially Equivalent	Surgical Instrument Service and Savings Inc.(Dba Medline Ren
K240826	Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter	Oct 11, 2024	Substantially Equivalent	Sterilmed, Inc.
K241156	Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401	Sep 14, 2024	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K240972	Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)	Jun 07, 2024	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K233825	Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter	Jun 07, 2024	Substantially Equivalent	Innovative Health
K221067	Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter	May 31, 2023	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K221854	Reprocesses Umbilical Cable	Aug 06, 2022	Substantially Equivalent	Innovative Health, LLC
K211276	Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters	Sep 15, 2021	Substantially Equivalent	Innovative Health, LLC
K203655	Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)	May 04, 2021	Substantially Equivalent	Innovative Health, LLC
K200205	Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled	May 13, 2020	Substantially Equivalent	Stryker Sustainability Solutions
K193263	Reprocessed Achieve Catheter Connecting Cable	Jan 24, 2020	Substantially Equivalent	Innovative Health, LLC
K191170	Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter	Oct 30, 2019	Substantially Equivalent	Innovative Health, LLC
K190127	Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter	Aug 23, 2019	Substantially Equivalent	Innovative Health, LLC
K182488	Reprocessed Response Diagnostic Electrophysiology Catheter	Feb 22, 2019	Substantially Equivalent	Innovative Health, LLC
K181056	Reprocessed CS Diagnostic Electrophysiology Catheter	Jan 24, 2019	Substantially Equivalent	Stryker Sustainability Solutions
K181897	Reprocessed Marinr Diagnostic EP Catheter	Nov 15, 2018	Substantially Equivalent	Innovative Health, LLC
K181458	Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter	Oct 27, 2018	Substantially Equivalent	Innovative Health, LLC
K181618	Reprocessed Torqr Diagnostic EP Catheter	Oct 18, 2018	Substantially Equivalent	Innovative Health, LLC
K180710	Reprocessed DecaNav Diagnostic Electrophysiology Catheter	Jun 19, 2018	Substantially Equivalent	Innovative Health, LLC
K171788	Reprocessed Halo XP Diagnostic Electrophysiology Catheter	Nov 03, 2017	Substantially Equivalent	Innovative Health, LLC
K171503	Reprocessed CristaCath Diagnostic Electrophysiology Catheter	Oct 05, 2017	Substantially Equivalent	Innovative Health, LLC
K170922	Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)	Jun 22, 2017	Substantially Equivalent	Innovative Health, LLC
K161272	Supreme and Response Electrophysiology Catheters	May 18, 2017	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K162251	Reprocessed Viking Diagnostic Electrophysiology Catheters	Dec 21, 2016	Substantially Equivalent	Innovative Health, LLC
K161827	Reprocessed Response Diagnostic Electrophysiology Catheters	Dec 08, 2016	Substantially Equivalent	Innovative Health, LLC
K160421	Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter	Nov 02, 2016	Substantially Equivalent	Innovative Health, LLC
K161393	Reprocessed Orbiter ST Steerable Diagnostic EP Catheter	Oct 26, 2016	Substantially Equivalent	Innovative Health, LLC
K161464	Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters	Sep 30, 2016	Substantially Equivalent	Innovative Health, LLC
K153006	Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter	Jun 23, 2016	Substantially Equivalent	Sterilmed, Inc.
K160496	Reprocessed Inquiry Steerable Diagnostic EP Catheter	Jun 10, 2016	Substantially Equivalent	Innovative Health, LLC
K160303	Reprocessed Polaris X Steerable Diagnostic EP Catheter	May 10, 2016	Substantially Equivalent	Innovative Health, LLC
K160242	Reprocessed Livewire Steerable Diagnostic EP Catheter	May 10, 2016	Substantially Equivalent	Innovative Health, LLC
K153153	Reprocessed Electrophysiology Catheter	Mar 14, 2016	Substantially Equivalent	Innovative Health, LLC
K151617	Livewire Electrophysiology Catheter	Jan 22, 2016	Substantially Equivalent	Surgical Instrument Service and Savings Inc.(Dba Medline Ren
K150357	Reprocessed Electrophysiology Diagnostic Catheters	Aug 27, 2015	Substantially Equivalent	Sterilmed, Inc.
K121158	REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS	Aug 06, 2012	Substantially Equivalent	Sterilmed, Inc.
K112292	REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER	Oct 21, 2011	Substantially Equivalent	Stryker Sustainability Solutions
K112232	REPROCESSED ELECTROPHYSIOLOGY CATHETERS	Sep 26, 2011	Substantially Equivalent	Stryker Sustainability Solutions
K101789	REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS	Aug 19, 2010	Substantially Equivalent	Sterilmed, Inc.
K100254	REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER	May 28, 2010	Substantially Equivalent	Ascent Healthcare Solutions
K092158	REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS	Jan 14, 2010	Substantially Equivalent	Sterilmed, Inc.
K090323	REPROCESSED ELECTROPHYSIOLOGY CATHETERS	Apr 01, 2009	Substantially Equivalent	Ascent Healthcare Solutions
K082023	REPROCESSED ELECTROPHYSIOLOGY CATHETERS	Sep 16, 2008	Substantially Equivalent	Ascent Healthcare Solutions
K081329	REPROCESSED ELECTROPHYSIOLOGY CATHETERS	Jul 09, 2008	Substantially Equivalent	Ascent Healthcare Solutions
K061045	REPROCESSED ELECTROPHYSIOLOGY CATHETERS	Aug 31, 2006	Substantially Equivalent	Alliance Medical Corp.
K052603	REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS	Nov 16, 2005	Substantially Equivalent	Alliance Medical Corp.
K052414	REPROCESSED ELECTROPHYSIOLOGY CATHETER	Nov 16, 2005	Substantially Equivalent	Alliance Medical Corp.
K051220	REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS	Jun 14, 2005	Substantially Equivalent	Sterilmed, Inc.
K051043	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS	Jun 06, 2005	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K050763	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS	Jun 01, 2005	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K043392	REPROCESSED ELECTROPHYSIOLOGY CATHETERS	Mar 25, 2005	Substantially Equivalent	Alliance Medical Corp.
K043393	REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS	Mar 23, 2005	Substantially Equivalent	Alliance Medical Corp.
K040751	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS	Mar 10, 2005	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K042074	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS	Mar 09, 2005	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K043513	STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER	Mar 01, 2005	Substantially Equivalent	Sterilmed, Inc.
K030279	REPROCESSED ELECTROPHYSIOLOGY CATHETER	Oct 03, 2003	Substantially Equivalent	Alliance Medical Corp.
K030187	REPROCESSED ELECTROPHYSIOLOGY CATHETER	Sep 24, 2003	Substantially Equivalent	Alliance Medical, Inc.
K030109	ELECTROPHYSIOLOGY CATHETER	Aug 08, 2003	Substantially Equivalent	Alliance Medical Corp.
K030026	REPROCESSED ELECTROPHYSIOLOGY CATHETER	May 02, 2003	Substantially Equivalent	Alliance Medical Corp.
K030114	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS	Mar 21, 2003	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K023180	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS	Dec 12, 2002	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K022316	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS	Oct 10, 2002	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K012678	REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS	Aug 14, 2002	Substantially Equivalent	Sterilmed, Inc.
K012523	REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS	Aug 14, 2002	Substantially Equivalent	Sterilmed, Inc.
K012708	ELECTROPHYSIOLOGY CATHETER	Aug 13, 2002	Substantially Equivalent	Alliance Medical Corp.
K012687	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS	Aug 01, 2002	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K012688	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS	Jul 31, 2002	Substantially Equivalent	Vanguard Medical Concepts, Inc.