# K053440: Amplatzer Sizing Balloon II

- Pathway: 510(k) (Special)
- Applicant: Aga Medical Corp.
- Decided: Dec 30, 2005 after 21 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K941269 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993248: Amplatzer Sizing Balloon, Aga Medical Corp. (2000) Summary page 2.
- K003320: Pta-OS Sizing Balloon, Model 360, NuMED, Inc. (2001) Summary page 2.

## Recalls of this device
- Dec 17, 2010 · Not classified · Z-1595-2011: AGA Medical is initiating a voluntary recall of a specific lot of mislabeled AMPLATZER Sizing Balloon II. AGA Medical received 2 reports from customers who received sizing balloons that were labeled a
- Apr 25, 2008 · Not classified · Z-2193-2008: AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed 

## Indications for use
AMPLATZER® Sizing Balloon II is indicated for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

Source page: https://510kreport.com/device/K053440
Methodology: https://510kreport.com/methodology