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FDA 510(k)

REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS

K-Number: K043393 · 2005-03-23

ApplicantAlliance Medical Corp.
Decision Date2005-03-23
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Medical Corp.. It received FDA 510(k) clearance on 2005-03-23 under 510(k) number K043393. 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 EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS?

REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS is a medical device that received FDA 510(k) clearance on 2005-03-23. The listed applicant is Alliance Medical Corp.. The 510(k) number is K043393.

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

REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS received FDA 510(k) clearance on 2005-03-23, under 510(k) number K043393.

Who is the listed applicant for REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS?

The FDA 510(k) record lists Alliance Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS?

The FDA product code for REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS is NLH.

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Other records listing Alliance Medical Corp. 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.

K060648REPROCESSED PHACOEMULSIFICATION TIPSK061045REPROCESSED ELECTROPHYSIOLOGY CATHETERSK060049REPROCESSED COMPRESSION SLEEVESK060091ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVESK053316REPROCESSED COMPRESSION SLEEVESK052918REPROCESSED EXTERNAL FIXATION DEVICES

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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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