K900664

Substantially Equivalent

DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES

Applicant: Sterimed, Inc.
Product code: DRC
Advisory panel: Cardiovascular
Date received: 1990-02-13
Decision date: 1990-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cartersville, GA, US

Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.