CONTROL SYRINGE— 510(k) K960430

Substantially Equivalent

Scientific Device Manufacturer, LLC

FDA 510(k) clearance K960430 for CONTROL SYRINGE, Substantially Equivalent on 1996-08-06. Applicant: Scientific Device Manufacturer, LLC.

Clearance details

Applicant: Scientific Device Manufacturer, LLC
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1996-01-31
Decision date: 1996-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Rafael, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.