# K003320: Pta-OS Sizing Balloon, Model 360

- Pathway: 510(k) (Traditional)
- Applicant: NuMED, Inc.
- Decided: May 2, 2001 after 190 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K040830: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters (2004), 1 descendant of its own
- K153069: Edwards Balloon Catheter (2016), 0 descendants of its own
- K053440: Amplatzer Sizing Balloon II (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K003320
Methodology: https://510kreport.com/methodology