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510(k) K211276

Device
Reprocessed Dynamic Tip And XT Steerable Diagnostic Electrophysiology Catheters
Applicant
Innovative Health, LLC.
510(k) number
K211276
Product code
NLH  
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-15
Date received
2021-04-27
Regulation
870.1220
Classification name
Catheter, Recording, Electrode, Reprocessed
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rick Ferreira
Address
1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NLH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.2025-11-26
K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.2025-07-11
K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.2024-11-29
K241224Medline 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)Surgical Instrument Service and Savings Inc.(Dba Medline Ren2024-11-15
K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterSterilmed, Inc.2024-10-11
K241156Medline 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, 401Surgical Instrument Service and Savings, Inc.2024-09-14
K240972Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)Surgical Instrument Service and Savings, Inc.2024-06-07
K233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health2024-06-07
K221067Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterSurgical Instrument Service and Savings, Inc.2023-05-31
K221854Reprocesses Umbilical CableInnovative Health, LLC2022-08-06
K203655Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)Innovative Health, LLC2021-05-04
K200205Reprocessed Advisor FL Circular Mapping Catheter, Sensor EnabledStryker Sustainability Solutions2020-05-13
K193263Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC2020-01-24
K191170Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology CatheterInnovative Health, LLC2019-10-30
K190127Reprocessed Livewire Steerable Diagnostic Electrophysiology CatheterInnovative Health, LLC2019-08-23

Legacy Summary#

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FDA Review#

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