S.C.T. MULTI PORT, INJECTION SITE— 510(k) K864296

Substantially Equivalent

Salt Creek Medical Technologies

FDA 510(k) clearance K864296 for S.C.T. MULTI PORT, INJECTION SITE, Substantially Equivalent on 1987-03-02. Applicant: Salt Creek Medical Technologies.

Clearance details

Applicant: Salt Creek Medical Technologies
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1986-10-31
Decision date: 1987-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canfield, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.