# K952063: XXL Ballon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 14, 1995 after 196 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K970725: Opti-Plast XL 5.5 F Pta Catheter (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K952063
Methodology: https://510kreport.com/methodology