Atlas FDA

NLH

70 FDA 510(k) clearances · Product code

133 daysmedian time to decision
351 days90th percentile
70clearances measured

FDA profile

Official device name
Catheter, Recording, Electrode, Reprocessed
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1220
Medical specialty
Cardiovascular
FDA 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).
Adverse events (MAUDE)
2020: 28 · 2021: 55 · 2023: 30 · 2024: 47 · 2025: 66 · 2026: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter (K252405)Surgical Instrument Service and Savings, Inc.2025-11-26
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter (K250772)Surgical Instrument Service and Savings, Inc.2025-07-11
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (K242225)Surgical Instrument Service and Savings, Inc.2024-11-29
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) (K241224)Surgical Instrument Service and Savings Inc.(Dba Medline Ren2024-11-15
Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (K240826)Sterilmed, Inc.2024-10-11
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 (K241156)Surgical Instrument Service and Savings, Inc.2024-09-14
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (K233825)Innovative Health2024-06-07
Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (K240972)Surgical Instrument Service and Savings, Inc.2024-06-07
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter (K221067)Surgical Instrument Service and Savings, Inc.2023-05-31
Reprocesses Umbilical Cable (K221854)Innovative Health, LLC2022-08-06
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters (K211276)Innovative Health, LLC2021-09-15
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) (K203655)Innovative Health, LLC2021-05-04
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled (K200205)Stryker Sustainability Solutions2020-05-13
Reprocessed Achieve Catheter Connecting Cable (K193263)Innovative Health, LLC2020-01-24
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter (K191170)Innovative Health, LLC2019-10-30
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter (K190127)Innovative Health, LLC2019-08-23
Reprocessed Response Diagnostic Electrophysiology Catheter (K182488)Innovative Health, LLC2019-02-22
Reprocessed CS Diagnostic Electrophysiology Catheter (K181056)Stryker Sustainability Solutions2019-01-24
Reprocessed Marinr Diagnostic EP Catheter (K181897)Innovative Health, LLC2018-11-15
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter (K181458)Innovative Health, LLC2018-10-27
Reprocessed Torqr Diagnostic EP Catheter (K181618)Innovative Health, LLC2018-10-18
Reprocessed DecaNav Diagnostic Electrophysiology Catheter (K180710)Innovative Health, LLC2018-06-19
Reprocessed Halo XP Diagnostic Electrophysiology Catheter (K171788)Innovative Health, LLC2017-11-03
Reprocessed CristaCath Diagnostic Electrophysiology Catheter (K171503)Innovative Health, LLC2017-10-05
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) (K170922)Innovative Health, LLC2017-06-22
Supreme and Response Electrophysiology Catheters (K161272)Surgical Instrument Service and Savings, Inc.2017-05-18
Reprocessed Viking Diagnostic Electrophysiology Catheters (K162251)Innovative Health, LLC2016-12-21
Reprocessed Response Diagnostic Electrophysiology Catheters (K161827)Innovative Health, LLC2016-12-08
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter (K160421)Innovative Health, LLC2016-11-02
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter (K161393)Innovative Health, LLC2016-10-26
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters (K161464)Innovative Health, LLC2016-09-30
Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter (K153006)Sterilmed, Inc.2016-06-23
Reprocessed Inquiry Steerable Diagnostic EP Catheter (K160496)Innovative Health, LLC2016-06-10
Reprocessed Livewire Steerable Diagnostic EP Catheter (K160242)Innovative Health, LLC2016-05-10
Reprocessed Polaris X Steerable Diagnostic EP Catheter (K160303)Innovative Health, LLC2016-05-10
Reprocessed Electrophysiology Catheter (K153153)Innovative Health, LLC2016-03-14
Livewire Electrophysiology Catheter (K151617)Surgical Instrument Service and Savings Inc.(Dba Medline Ren2016-01-22
Reprocessed Electrophysiology Diagnostic Catheters (K150357)Sterilmed, Inc.2015-08-27
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K121158)Sterilmed, Inc.2012-08-06
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER (K112292)Stryker Sustainability Solutions2011-10-21
REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K112232)Stryker Sustainability Solutions2011-09-26
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K101789)Sterilmed, Inc.2010-08-19
REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (K100254)Ascent Healthcare Solutions2010-05-28
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K092158)Sterilmed, Inc.2010-01-14
REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K090323)Ascent Healthcare Solutions2009-04-01
REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K082023)Ascent Healthcare Solutions2008-09-16
REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K081329)Ascent Healthcare Solutions2008-07-09
REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K061045)Alliance Medical Corp.2006-08-31
REPROCESSED ELECTROPHYSIOLOGY CATHETER (K052414)Alliance Medical Corp.2005-11-16
REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS (K052603)Alliance Medical Corp.2005-11-16
REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K051220)Sterilmed, Inc.2005-06-14
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K051043)Vanguard Medical Concepts, Inc.2005-06-06
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K050763)Vanguard Medical Concepts, Inc.2005-06-01
REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K043392)Alliance Medical Corp.2005-03-25
REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS (K043393)Alliance Medical Corp.2005-03-23
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K040751)Vanguard Medical Concepts, Inc.2005-03-10
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K042074)Vanguard Medical Concepts, Inc.2005-03-09
STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER (K043513)Sterilmed, Inc.2005-03-01
REPROCESSED ELECTROPHYSIOLOGY CATHETER (K030279)Alliance Medical Corp.2003-10-03
REPROCESSED ELECTROPHYSIOLOGY CATHETER (K030187)Alliance Medical, Inc.2003-09-24
ELECTROPHYSIOLOGY CATHETER (K030109)Alliance Medical Corp.2003-08-08
REPROCESSED ELECTROPHYSIOLOGY CATHETER (K030026)Alliance Medical Corp.2003-05-02
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K030114)Vanguard Medical Concepts, Inc.2003-03-21
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K023180)Vanguard Medical Concepts, Inc.2002-12-12
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K022316)Vanguard Medical Concepts, Inc.2002-10-10
REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K012678)Sterilmed, Inc.2002-08-14
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K012523)Sterilmed, Inc.2002-08-14
ELECTROPHYSIOLOGY CATHETER (K012708)Alliance Medical Corp.2002-08-13
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K012687)Vanguard Medical Concepts, Inc.2002-08-01
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K012688)Vanguard Medical Concepts, Inc.2002-07-31

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