Decision Date2024-06-07
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K233825. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Innovative Health. The 510(k) number is K233825.
When did Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter receive FDA 510(k) clearance?
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter received FDA 510(k) clearance on 2024-06-07, under 510(k) number K233825.
Who is the listed applicant for Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?
The FDA 510(k) record lists Innovative Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?
The FDA product code for Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is NLH.
Other records listing Innovative Health as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Related Devices (Code: NLH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.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 RenK240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterSterilmed, Inc.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.
Official Source
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