CURITY & KENGUARD SILICONE COATED FOLEY CATHETER— 510(k) K860484
Substantially EquivalentThe Kendal Co.
FDA 510(k) clearance K860484 for CURITY & KENGUARD SILICONE COATED FOLEY CATHETER, Substantially Equivalent on 1986-03-11. Applicant: The Kendal Co.. Device class: 2.
Clearance details
- Applicant
- The Kendal Co.
- Product code
- Code KOD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code KOD
view allMore clearances from The Kendal Co.
view all- K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
- K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
- K991758 — MONOJECT INSULIN SYRINGE
- K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
- K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
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 →
Recalls naming K860484
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K860484.
Data sourced from openFDA. This site is unofficial and independent of the FDA.