K992912

Substantially Equivalent

CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH

Applicant: Cardiac Pathways Corp.
Product code: DRF
Advisory panel: Cardiovascular
Date received: 1999-08-30
Decision date: 2000-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.