# K930129: Arrow Picc-Peripherally Inserted Central Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Mar 28, 1994 after 440 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K040100: Arrow Echogenic Introducer Needle (2004), 1 descendant of its own
- K071998: Arrow Echogenic Introducer Needle Component (2007), 0 descendants of its own
- K042126: PICC (2004), 0 descendants of its own

## Recalls of this device
- Apr 11, 2018 · Class II · Z-2021-2018: Product sterility may be compromised due to unsealed packaging.
- Jan 11, 2017 · Class II · Z-1228-2017: There have been complaints for peel away sheaths flaring
- Sep 21, 2004 · Not classified · Z-0552-05: Product was mislabeled for lumen configuration, flow rates, and priming volume.
- Sep 21, 2004 · Not classified · Z-0551-05: Product was mislabeled for lumen configuration, flow rates, and priming volume.

Source page: https://510kreport.com/device/K930129
Methodology: https://510kreport.com/methodology