# K122379: Flash Pta Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash Pta Balloon Dilatation Catheter - 4MM X 19MM X 135CM

- Pathway: 510(k) (Special)
- Applicant: Ostial Corporation
- Decided: Sep 5, 2012 after 30 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001134 (2000). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121175: Flash Pta Ballon Dilatation Catheter-5MM X 19MM X 135CM, Ostial Corporation (2012) Summary page 2.
- K120738: Flash Pta Balloon Dilatation Catheter-4.0X14MMX135CM, Ostial Corporation (2012) Summary page 1.

## Most influential descendants
- K133861: Flash Ostial System Otw-7.0MMX17MMX135CM, Flash Ostial System Otw-7.0MMX17MMX80CM (2014), 1 descendant of its own
- K150946: FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm (2015), 0 descendants of its own

## Recalls of this device
- Jul 14, 2021 · Class II · Z-2309-2021: Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.

## Indications for use
The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K122379
Methodology: https://510kreport.com/methodology