STRATUM D— 510(k) K874697

Substantially Equivalent

Alternative Design Systems, Inc.

FDA 510(k) clearance K874697 for STRATUM D, Substantially Equivalent on 1987-12-15. Applicant: Alternative Design Systems, Inc..

Clearance details

Applicant: Alternative Design Systems, Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1987-11-19
Decision date: 1987-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlstadt, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.