# K944016: Focus Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Dynamics, Inc.
- Decided: Dec 20, 1994 after 126 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 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
- K022061: Cvsi Peripheral Balloon Catheter; Cvsi Inflater (2002), 9 descendants of its own
- K040155: Peripheral Cutting Balloon (2004), 6 descendants of its own
- K051254: Peripheral Cutting Balloon (2005), 5 descendants of its own
- K041993: 2 CM Peripheral Cutting Baloon (2004), 5 descendants of its own
- K052038: Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System (2005), 4 descendants of its own

Source page: https://510kreport.com/device/K944016
Methodology: https://510kreport.com/methodology