ARGYLE INDWELL FEEDING TUBE
FDA 510(k) clearance K820442 · decided 1982-03-10
Clearance details
- K-number
- K820442
- Device name
- ARGYLE INDWELL FEEDING TUBE
- Applicant
- Sherwood Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-18
- Decision date
- 1982-03-10
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 recall (Z-1033-2016) | Covidien LLC | 2016-03-02 |
| Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr recall (Z-1034-2016) | Covidien LLC | 2016-03-02 |