# K112896: Arrw Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International (Subsidiary of Teleflex Inc.)
- Decided: May 10, 2012 after 223 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: 11 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 27 ancestors in all.
12 later devices descend from it; 4 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)
- K100635: Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002, S-45041-002, S-45504, Arrow Intl., Inc. (2010) Summary page 1.
- K083763: Zeus CT Picc 4 FR and 5 FR Single and Dual Lumen, R4 Vascular, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K122545: CG+ Arrow Picc Powered by Arrow VPS Stylet (2012), 2 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2378-2026: 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
- Apr 23, 2019 · Class II · Z-1819-2019: Lidstock states the incorrect expiration date for the product
- Apr 23, 2019 · Class II · Z-1811-2019: Lidstock states the incorrect expiration date for the product
- Apr 23, 2019 · Class II · Z-1822-2019: Lidstock states the incorrect expiration date for the product
- Apr 23, 2019 · Class II · Z-1820-2019: Lidstock states the incorrect expiration date for the product
- Dec 22, 2017 · Class II · Z-1327-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Nov 27, 2017 · Class II · Z-0996-2018: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Jun 12, 2017 · Class II · Z-2698-2017: Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may p
- May 9, 2017 · Class II · Z-2331-2017: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- Mar 3, 2017 · Class II · Z-1705-2017: Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of 
- Oct 16, 2015 · Class II · Z-0207-2016: Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a signi

## Indications for use
The ArrowEVOLUTIONTM Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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 ArrowEVOLUTIONTM Pressure Injectable PICC may not exceed 300 psi. Chlorag+ard Technology 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 and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.

Source page: https://510kreport.com/device/K112896
Methodology: https://510kreport.com/methodology