# K003006: Two-Lumen Picc with Blue Flextip Catheter and Integral Needle Protection

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Oct 27, 2000 after 31 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
4 of 10 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K021120: Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP (2002), 7 descendants of its own
- K151513: Arrow Endurance Extended Dwell Peripheral Catheter System (2015), 4 descendants of its own
- K152272: Arrow Endurance Extended Dwell Peripheral Catheter System (2015), 3 descendants of its own
- K163513: Arrow Endurance Extended Dwell Peripheral Catheter System (2017), 2 descendants of its own
- K243599: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (2025), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2395-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Aug 27, 2015 · Class II · Z-2825-2015: Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products.

Source page: https://510kreport.com/device/K003006
Methodology: https://510kreport.com/methodology