DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER— 510(k) K942379

Substantially Equivalent

Daig Corp.

FDA 510(k) clearance K942379 for DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, Substantially Equivalent on 1994-12-27. Applicant: Daig Corp..

Clearance details

Applicant: Daig Corp.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1994-05-09
Decision date: 1994-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, 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.