# K132567: Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted Central Catheter Dual Lumen

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Nov 5, 2013 after 82 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: 2 generations back to K920755 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K042461: Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304, Kendall (2004) Summary page 1.
- K061936: Kendall Argyle Neonatal/Pediatric Picc, Model 43311, The Kendall Company (2006) Summary page 1.

## 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 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 as other commonly used intravenous medications.

Source page: https://510kreport.com/device/K132567
Methodology: https://510kreport.com/methodology