ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER
FDA 510(k) clearance K941814 · decided 1994-09-30
Clearance details
- K-number
- K941814
- Device name
- ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER
- Applicant
- Sherwood Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1994-04-12
- Decision date
- 1994-09-30
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- FOS
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen recall (Z-1874-2025) | Cardinal Health 200, LLC | 2025-05-29 |