S80 IMPLANTABLE CARDIAC PACING LEAD— 510(k) K854963

Substantially Equivalent

Sorin Biomedica, Fiat, USA, Inc.

FDA 510(k) clearance K854963 for S80 IMPLANTABLE CARDIAC PACING LEAD, Substantially Equivalent on 1986-06-24. Applicant: Sorin Biomedica, Fiat, USA, Inc..

Clearance details

Applicant: Sorin Biomedica, Fiat, USA, Inc.
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1985-12-11
Decision date: 1986-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Italy, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTB

product code DTB

Death: 1,491
Injury: 67,311
Malfunction: 79,368
Other: 10
Total: 148,180

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.