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FDA 510(k)

Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter

K-Number: K240826 · 2024-10-11

ApplicantSterilmed, Inc.
Decision Date2024-10-11
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K240826. 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 DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter?

Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Sterilmed, Inc.. The 510(k) number is K240826.

When did Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter receive FDA 510(k) clearance?

Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter received FDA 510(k) clearance on 2024-10-11, under 510(k) number K240826.

Who is the listed applicant for Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter?

The FDA 510(k) record lists Sterilmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter?

The FDA product code for Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is NLH.

Other records listing Sterilmed, Inc. as applicant

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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 RenK241156Medline 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.K240972Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)Surgical Instrument Service and Savings, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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