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FDA 510(k)

REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

K-Number: K092158 · 2010-01-14

ApplicantSterilmed, Inc.
Decision Date2010-01-14
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2010-01-14 under 510(k) number K092158. 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 ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS?

REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS is a medical device that received FDA 510(k) clearance on 2010-01-14. The listed applicant is Sterilmed, Inc.. The 510(k) number is K092158.

When did REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS receive FDA 510(k) clearance?

REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS received FDA 510(k) clearance on 2010-01-14, under 510(k) number K092158.

Who is the listed applicant for REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS?

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 ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS?

The FDA product code for REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS is NLH.

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Related Devices (Code: NLH)

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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

View on FDA Database →

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

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