# K934191: New Blue Max Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 9, 1993 after 105 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.
14 later devices descend from it; 1 cites it directly.
0 of 15 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
- K973013: Opti-Plast (Centurion) 5.5F Angioplasty Catheter (1998), 13 descendants of its own
- K040243: Bard Atlas Pta Balloon Dilatation Catheter (2004), 11 descendants of its own
- K052236: Bard Atlas Pta Balloon Dilatation Catheter (2005), 10 descendants of its own
- K120971: Atlas Pta Balloon Dilatation Catheter (2012), 9 descendants of its own
- K122984: Atlas Gold Pta Dilatation Catheter (2012), 7 descendants of its own

Source page: https://510kreport.com/device/K934191
Methodology: https://510kreport.com/methodology