PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE— 510(k) K853207

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K853207 for PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE, Substantially Equivalent on 1985-09-12. Applicant: American Pharmaseal Div. Ahsc.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1985-07-31
Decision date: 1985-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.