# K950118: Abrm Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Feb 8, 1996 after 393 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.
134 later devices descend from it; 2 cite it directly.
15 of 135 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K021557: Spectrum Silicone Catheter (2003), 126 descendants of its own
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line (2005), 119 descendants of its own
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter (2007), 66 descendants of its own
- K061179: Powerhickman Long-Term Intravascular Catheter (2006), 47 descendants of its own
- K033843: Spectrum Central Venous Catheter with or Without Hydrophilic Coating (2004), 33 descendants of its own

## Recalls of this device
- Jan 2, 2007 · Not classified · Z-0637-2007: These catheters do not include the proximal sidehole as required by the specification.

Source page: https://510kreport.com/device/K950118
Methodology: https://510kreport.com/methodology