DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
FDA 510(k) clearance K024010 · decided 2003-06-11
Clearance details
- K-number
- K024010
- Device name
- DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
- Applicant
- The Kendall Company Div. of Tyco Healthcare Group
- Decision
- Substantially Equivalent
- Date received
- 2002-12-04
- Decision date
- 2003-06-11
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mansfield, 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, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN recall (Z-1050-2024) | Cardinal Health 200, LLC | 2024-02-16 |