CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
FDA 510(k) clearance K860484 · decided 1986-03-11
Clearance details
- K-number
- K860484
- Device name
- CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
- Applicant
- The Kendal Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-10
- Decision date
- 1986-03-11
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAI recall (Z-1052-2024) | Cardinal Health 200, LLC | 2024-02-16 |