ELECATH PLASTIC JACKETED GUIDEWIRE— 510(k) K780493

Substantially Equivalent

Electro-Catheter Corp.

FDA 510(k) clearance K780493 for ELECATH PLASTIC JACKETED GUIDEWIRE, Substantially Equivalent on 1978-04-10. Applicant: Electro-Catheter Corp..

Clearance details

Applicant: Electro-Catheter Corp.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1978-03-27
Decision date: 1978-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.