# K080604: Pressure Injfectable Picc

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc.
- Decided: Jun 27, 2008 after 115 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 24 ancestors in all.
18 later devices descend from it; 4 cite it directly.
10 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073451: Pressure Injectable Picc, Arrow International, Inc. (2008) Summary page 1.
- K053501: Powerpicc, Bard Access Systems, Inc. (2006) Summary page 1.
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line, C.R. Bard, Inc. (2005)

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

## Recalls of this device
- Apr 11, 2018 · Class II · Z-2024-2018: Product sterility may be compromised due to unsealed packaging.

## Indications for use
The 6 Fr. Triple Lumen Pressure Injectable Peripherally Inserted Central Catheter is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.

Source page: https://510kreport.com/device/K080604
Methodology: https://510kreport.com/methodology