DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES— 510(k) K900664

Substantially Equivalent

Sterimed, Inc.

FDA 510(k) clearance K900664 for DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES, Substantially Equivalent on 1990-07-18. Applicant: Sterimed, Inc..

Clearance details

Applicant: Sterimed, Inc.
Product code: 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

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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.