Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CARDIO MED

K-Number: K103334 · 2011-01-18

ApplicantCardio Medical Products, Inc.
Decision Date2011-01-18
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO MED is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Medical Products, Inc.. It received FDA 510(k) clearance on 2011-01-18 under 510(k) number K103334. 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 CARDIO MED?

CARDIO MED is a medical device that received FDA 510(k) clearance on 2011-01-18. The listed applicant is Cardio Medical Products, Inc.. The 510(k) number is K103334.

When did CARDIO MED receive FDA 510(k) clearance?

CARDIO MED received FDA 510(k) clearance on 2011-01-18, under 510(k) number K103334.

Who is the listed applicant for CARDIO MED?

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

What is the FDA product code for CARDIO MED?

The FDA product code for CARDIO MED 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 Cardio Medical Products, 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.

K103651CARDIOMEDK103159CARDIO MED MODEL A102, H104, O101, P103, AND Z100

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 SpaK103159CARDIO MED MODEL A102, H104, O101, P103, AND Z100Cardio Medical Products, 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.

↑