# K001134: Gazelle Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 31, 2000 after 143 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.
175 later devices descend from it; 2 cite it directly.
0 of 176 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
- K021735: Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter (2002), 165 descendants of its own
- K050389: Ultra-Soft SV Balloon Dilatation Catheter (2005), 164 descendants of its own
- K053116: Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx (2005), 133 descendants of its own
- K072283: Dorado Pta Balloon Dilatation Catheter (2007), 96 descendants of its own
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx (2005), 62 descendants of its own

Source page: https://510kreport.com/device/K001134
Methodology: https://510kreport.com/methodology