# K061936: Kendall Argyle Neonatal/Pediatric Picc, Model 43311

- Pathway: 510(k) (Special)
- Applicant: The Kendall Company
- Decided: Aug 9, 2006 after 30 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974015 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974015: Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick- Picc Peripherally Inserted Central, Davis & Geck, Inc. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K042461: Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304, Kendall (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K132567: Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted Central Catheter Dual Lumen (2013), 0 descendants of its own

## Indications for use
The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well other commonly used intravenous medications.

Source page: https://510kreport.com/device/K061936
Methodology: https://510kreport.com/methodology