# K073451: Pressure Injectable Picc

- Pathway: 510(k) (Special)
- Applicant: Arrow International, Inc.
- Decided: Jan 15, 2008 after 36 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K041420 (2004). 2 ancestors in all.
19 later devices descend from it; 2 cite it directly.
8 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061289: Arrow Pressure Injectable Picc, Arrow International, Inc. (2006) Summary page 1.

## Most influential descendants
- K080604: Pressure Injfectable Picc (2008), 18 descendants of its own
- K100635: Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002, S-45041-002, S-45504 (2010), 14 descendants of its own
- K112896: Arrw Evolution (2012), 12 descendants of its own
- K121501: Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) (2012), 4 descendants of its own
- K132133: CG+ Arrow Jacc Powered by Arrow VPS Stylet (2013), 3 descendants of its own

## Recalls of this device
- Aug 10, 2023 · Class II · Z-2590-2023: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Sep 18, 2015 · Class II · Z-0127-2016: Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC 
- Jul 30, 2015 · Class II · Z-2462-2015: the catheter peel-away component hub tabs may prematurely detach. One injury reported.
- Jul 30, 2015 · Class II · Z-2489-2015: saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.
- Aug 6, 2014 · Class II · Z-0066-2015: The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and 
- Mar 29, 2010 · Not classified · Z-1682-2010: Tight fit in sheath. Arrow has received complaints of the PICC catheter fitting too tightly in the "kit supplied" peelable sheath. In some cases, clinicians have been unable to insert the catheter thr

## Indications for use
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.

Source page: https://510kreport.com/device/K073451
Methodology: https://510kreport.com/methodology