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FDA 510(k)

ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR

K-Number: K011461 · 2002-05-28

ApplicantAccess Cardiosystems, Inc.
Decision Date2002-05-28
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Access Cardiosystems, Inc.. It received FDA 510(k) clearance on 2002-05-28 under 510(k) number K011461. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR?

ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 2002-05-28. The listed applicant is Access Cardiosystems, Inc.. The 510(k) number is K011461.

When did ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR receive FDA 510(k) clearance?

ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR received FDA 510(k) clearance on 2002-05-28, under 510(k) number K011461.

Who is the listed applicant for ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR?

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

What is the FDA product code for ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR?

The FDA product code for ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR is LDD.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Access Cardiosystems, 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.

K020984ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS

Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, 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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