KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304
FDA 510(k) clearance K042461 · decided 2004-12-10
Clearance details
- K-number
- K042461
- Device name
- KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304
- Applicant
- Kendall
- Decision
- Substantially Equivalent
- Date received
- 2004-09-10
- Decision date
- 2004-12-10
- Days to decision
- 91 days
- Clearance type
- Abbreviated
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC recall (Z-0932-05) | Kendall Healthcare Products Co | 2005-06-25 |