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FDA 510(k)

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

K-Number: K012688 · 2002-07-31

ApplicantVanguard Medical Concepts, Inc.
Decision Date2002-07-31
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Vanguard Medical Concepts, Inc.. It received FDA 510(k) clearance on 2002-07-31 under 510(k) number K012688. 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 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS?

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS is a medical device that received FDA 510(k) clearance on 2002-07-31. The listed applicant is Vanguard Medical Concepts, Inc.. The 510(k) number is K012688.

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

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS received FDA 510(k) clearance on 2002-07-31, under 510(k) number K012688.

Who is the listed applicant for VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS?

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

What is the FDA product code for VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS?

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

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Other records listing Vanguard Medical Concepts, Inc. 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.

K053051VANGUARD REPROCESSED EXTERNAL FIXATION DEVICESK051616VANGUARD REPROCESSED EXTERNAL FIXATION DEVICESK051180VANGUARD REPROCESSED EXTERNAL FIXATION DEVICESK051043VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERSK050763VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERSK043198VANGUARD REPROCESSED ARTHROSCOPIC WANDS

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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

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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