MODEL #340 STEALTH-TRODE+LS— 510(k) K923297

Substantially Equivalent

Cardiotronics, Inc.

FDA 510(k) clearance K923297 for MODEL #340 STEALTH-TRODE+LS, Substantially Equivalent on 1992-09-18. Applicant: Cardiotronics, Inc..

Clearance details

Applicant: Cardiotronics, Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1992-07-06
Decision date: 1992-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Carlsbad, CA, US

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.