FDA 510(k)

REPROCESSED ELECTROPHYSIOLOGY CATHETERS

K-Number: K061045 · 2006-08-31

Decision Date2006-08-31

Product CodeNLH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

REPROCESSED 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 2006-08-31 under 510(k) number K061045. 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 CATHETERS?

REPROCESSED ELECTROPHYSIOLOGY CATHETERS is a medical device that received FDA 510(k) clearance on 2006-08-31. The listed applicant is Alliance Medical Corp.. The 510(k) number is K061045.

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

REPROCESSED ELECTROPHYSIOLOGY CATHETERS received FDA 510(k) clearance on 2006-08-31, under 510(k) number K061045.

Who is the listed applicant for REPROCESSED 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 ELECTROPHYSIOLOGY CATHETERS?

The FDA product code for REPROCESSED ELECTROPHYSIOLOGY CATHETERS is NLH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alliance Medical Corp. as applicant

K060648REPROCESSED PHACOEMULSIFICATION TIPS K060049REPROCESSED COMPRESSION SLEEVES K060091ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES K053316REPROCESSED COMPRESSION SLEEVES K052918REPROCESSED EXTERNAL FIXATION DEVICES K052414REPROCESSED ELECTROPHYSIOLOGY CATHETER

View all 36 devices →

Related Devices (Code: NLH)

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 Ren K240826Reprocessed 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.