ROSETTA-LT/ROSETTA-RX— 510(k) K002089

Substantially Equivalent

General Devices

FDA 510(k) clearance K002089 for ROSETTA-LT/ROSETTA-RX, Substantially Equivalent on 2000-11-21. Applicant: General Devices.

Clearance details

Applicant: General Devices
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2000-07-11
Decision date: 2000-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridgefield, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.