700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES— 510(k) K964991

Name: FDA 510(k) clearance K964991
Creator: U.S. Food and Drug Administration
Published: 1997-01-15

Substantially Equivalent

Cardiotronics Systems, Inc.

FDA 510(k) clearance K964991 for 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES, Substantially Equivalent on 1997-01-15. Applicant: Cardiotronics Systems, Inc.. Device class: 3.

Clearance details

Applicant: Cardiotronics Systems, Inc.
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 1996-12-13
Decision date: 1997-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cardiotronics Systems, Inc.

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K971148 — 700-SP SERIES DISPOSABLE STIMULATION ELECTRODES1997-05-15
K970719 — 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES1997-04-16
K964469 — 700-F SERIES STIMULATION ELECTRODES1996-12-11

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.