# K993248: Amplatzer Sizing Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Aga Medical Corp.
- Decided: Jul 12, 2000 after 288 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
Longest line of descent: 2 generations back to K941269 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962765: Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom with Radiopaque Markers), Cordis Corp. (1997) Summary page 2.

## Most influential descendants
- K053440: Amplatzer Sizing Balloon II (2005), 0 descendants of its own

## Indications for use
The AMPLATZER® Sizing Balloon 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/K993248
Methodology: https://510kreport.com/methodology