SAFE-1— 510(k) K893704

Substantially Equivalent

Polystan C/O Vitalcor, Inc.

FDA 510(k) clearance K893704 for SAFE-1, Substantially Equivalent on 1989-12-22. Applicant: Polystan C/O Vitalcor, Inc..

Clearance details

Applicant: Polystan C/O Vitalcor, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1989-05-18
Decision date: 1989-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

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.