PIDURAL STEROID SYSTEM— 510(k) K945484

Unknown

Professional Medical Device Consultants

FDA 510(k) clearance K945484 for PIDURAL STEROID SYSTEM, Unknown on 1995-06-02. Applicant: Professional Medical Device Consultants.

Clearance details

Applicant: Professional Medical Device Consultants
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 1994-11-08
Decision date: 1995-06-02
Decision: Unknown
Clearance type: Traditional
Location: Sandy, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.