TRACER O-T-W MAPPING DEVICE— 510(k) K972803

Substantially Equivalent

Cardima, Inc.

FDA 510(k) clearance K972803 for TRACER O-T-W MAPPING DEVICE, Substantially Equivalent on 1999-05-11. Applicant: Cardima, Inc..

Clearance details

Applicant: Cardima, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1997-07-28
Decision date: 1999-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, 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.