KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR— 510(k) K933400
Substantially EquivalentKendall Healthcare Products Co. Div.Of Tyco Health
FDA 510(k) clearance K933400 for KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR, Substantially Equivalent on 1993-11-15. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health.
Clearance details
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Product code
- Code KOD
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Adverse events under product code KOD
product code KOD- Death
- 5
- Injury
- 1,129
- Malfunction
- 7,019
- Total
- 8,153
Source: openFDA MAUDE database, through . 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.