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FDA 510(k)

MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)

K-Number: K922172 · 1992-06-11

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

Device Summary

MODEL # 230 ST STEALTH-TRODE 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 K922172. 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 # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)?

MODEL # 230 ST STEALTH-TRODE 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 K922172.

When did MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) receive FDA 510(k) clearance?

MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) received FDA 510(k) clearance on 1992-06-11, under 510(k) number K922172.

Who is the listed applicant for MODEL # 230 ST STEALTH-TRODE 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 # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)?

The FDA product code for MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) is LDD.

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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)K922227MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILEK921606MODEL #125 CHILD STIMULATION PADS

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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.

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