# K963257: Peripherally Inserted Medline Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Mar 4, 1997 after 197 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K960113: Menlo Care Landmark Catheter. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K021130: Specath Central Venous Catheter Kits (2003), 2 descendants of its own
- K161313: ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (2016), 1 descendant of its own
- K070451: Able Central Venous Catheter (2007), 1 descendant of its own
- K213855: Arrow Pressure Injectable Midline Catheter (2022), 0 descendants of its own
- K193158: ACENT™ Central Venous Catheter (2020), 0 descendants of its own

## Recalls of this device
- May 17, 2018 · Class II · Z-2385-2018: Product pouch label may not easily identify the lot number, expiration date and associated symbols..

Source page: https://510kreport.com/device/K963257
Methodology: https://510kreport.com/methodology