510(k) K042461 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304
| Applicant | Kendall, Mansfield MA, US |
| Decision | Substantially Equivalent, Dec 10, 2004 |
| Received | Sep 10, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K042461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2005 | Kendall Healthcare Products Co Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged o Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.