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)

MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE

K-Number: K922227 · 1992-06-11

ApplicantCardiotronics, Inc.
Decision Date1992-06-11
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiotronics, Inc.. It received FDA 510(k) clearance on 1992-06-11 under 510(k) number K922227. 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 MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE?

MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE is a medical device that received FDA 510(k) clearance on 1992-06-11. The listed applicant is Cardiotronics, Inc.. The 510(k) number is K922227.

When did MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE receive FDA 510(k) clearance?

MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE received FDA 510(k) clearance on 1992-06-11, under 510(k) number K922227.

Who is the listed applicant for MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE?

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

What is the FDA product code for MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE?

The FDA product code for MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE 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 Cardiotronics, 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.

K932903EKG VESTK922064MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODEK923297MODEL #340 STEALTH-TRODE+LSK922173MODEL # 830 ST ADULT STIMULATION PADS (STERILE)K922172MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)K921606MODEL #125 CHILD STIMULATION PADS

View all 27 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑