K002230

Substantially Equivalent

CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002

Applicant: Cambridge Heart, Inc.
Product code: DRX
Advisory panel: Cardiovascular
Date received: 2000-07-24
Decision date: 2000-08-18
Decision: Substantially Equivalent
Clearance type: Special
Location: South West Ranches, FL, US

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.