ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER— 510(k) K852641

Substantially Equivalent

Sorin Biomedica, Fiat, USA, Inc.

FDA 510(k) clearance K852641 for ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER, Substantially Equivalent on 1986-01-14. Applicant: Sorin Biomedica, Fiat, USA, Inc..

Clearance details

Applicant: Sorin Biomedica, Fiat, USA, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1985-06-20
Decision date: 1986-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXY

product code DXY

Death: 240
Injury: 2,328
Malfunction: 2,096
Total: 4,664

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.