SWITCHING UNIT ELECTRODE CATHETER— 510(k) K834602

Substantially Equivalent

Webster Laboratories, Inc.

FDA 510(k) clearance K834602 for SWITCHING UNIT ELECTRODE CATHETER, Substantially Equivalent on 1984-05-09. Applicant: Webster Laboratories, Inc..

Clearance details

Applicant: Webster Laboratories, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1983-12-30
Decision date: 1984-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.