# K042461: Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304

- Pathway: 510(k) (Abbreviated)
- Applicant: Kendall
- Decided: Dec 10, 2004 after 91 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920755 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920755: L-Cath Peel Away System Catheter, Luther Medical Products, Inc. (1993) Summary page 4.
- K954302: Vygon Premi-Cath - Long Term Catheter, Vygon Corp. (1996) Summary page 4.
- K970434: Neo-Picc, Klein-Baker Medical, Inc. (1997) Summary page 4.
- K974015: Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick- Picc Peripherally Inserted Central, Davis & Geck, Inc. (1998) Summary page 4.

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

## Recalls of this device
- Apr 27, 2005 · Not classified · Z-0932-05: Holes in thermoformed tray compromising the sterility of the product.

## 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/K042461
Methodology: https://510kreport.com/methodology