# K992320: Megabello Percutaneous Transluminal Angioplasty (Pta) Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: May 18, 2000 after 311 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
Longest line of descent: 2 generations back to K913297 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972512: Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices Panel, Boston Scientific Scimed, Inc. (1998) Summary page 1.

## Indications for use
Megabello Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty (PTA) of the iliac and femoral vessels whose lumens are obstructed by atherosclerotic plaque. Megabello catheters are not indicated for use in coronary arteries nor in the neurovasculature. Any other use than those indicated is not recommended.

Source page: https://510kreport.com/device/K992320
Methodology: https://510kreport.com/methodology