# K100635: Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002, S-45041-002, S-45504

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Aug 27, 2010 after 175 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: 8 generations back to K001901 (2000). 25 ancestors in all.
14 later devices descend from it; 2 cite it directly.
9 of 40 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.
- K080604: Pressure Injfectable Picc, Arrow International, Inc. (2008) Summary page 6.

## Most influential descendants
- 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
- K123759: CG+ Arrow Picc Powered by Arrow VPS Stylet (2013), 3 descendants of its own
- K130876: CG+ Arrow Picc Powered by Arrow VPS Stylet (2013), 2 descendants of its own

## Indications for use
The Arrow Antimicrobial Pressure Injectable PICC is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

Source page: https://510kreport.com/device/K100635
Methodology: https://510kreport.com/methodology