HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML— 510(k) K142153

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K142153 for HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML, Substantially Equivalent on 2015-04-29. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2014-08-06
Decision date: 2015-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.