# K961552: CVP Polyurethane Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 10, 1997 after 294 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K061585: Opticath Central Venous Oximetry Catheter (2006), 1 descendant of its own
- K140129: Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry Catheter (2014), 0 descendants of its own

## Recalls of this device
- Dec 17, 2003 · Not classified · Z-0543-04: 18 gauge needles in Central Venous Catheter kits may be partially occluded.

Source page: https://510kreport.com/device/K961552
Methodology: https://510kreport.com/methodology