CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH— 510(k) K992912

Substantially Equivalent

Cardiac Pathways Corp.

FDA 510(k) clearance K992912 for CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH, Substantially Equivalent on 2000-03-08. Applicant: Cardiac Pathways Corp..

Clearance details

Applicant: Cardiac Pathways Corp.
Product code: 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.