# K061289: Arrow Pressure Injectable Picc

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc.
- Decided: Aug 24, 2006 after 107 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 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041420 (2004). 1 ancestor in all.
20 later devices descend from it; 3 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)
- K041420: Angiodynamics, Inc. Morpheus Picc and Procedure Kit, AngioDynamics, Inc. (2004) Summary page 1.

## Most influential descendants
- K073451: Pressure Injectable Picc (2008), 19 descendants of its own
- 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

## Recalls of this device
- Dec 20, 2019 · Class II · Z-1255-2020: Product lidstock contains the incorrect expiration date for the product
- Apr 11, 2018 · Class II · Z-2020-2018: Product sterility may be compromised due to unsealed packaging.
- Dec 22, 2017 · Class II · Z-1325-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- May 9, 2017 · Class II · Z-2338-2017: The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
- Feb 17, 2016 · Class II · Z-2772-2016: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
- Feb 17, 2016 · Class II · Z-2774-2016: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
- Feb 17, 2016 · Class II · Z-2771-2016: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
- Feb 17, 2016 · Class II · Z-2773-2016: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
- 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.
- 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/K061289
Methodology: https://510kreport.com/methodology