# K111284: Flash-C Ptca Balloon Dilation Catheter - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM

- Pathway: 510(k) (Traditional)
- Applicant: Ostial Corporation
- Decided: Aug 17, 2011 after 103 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Maverick XL Monorail PTCA Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K113775: Flash-C Ptca Balloon Dilatation Catheter- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM (2012), 4 descendants of its own
- K122178: Flash-C Ptca Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash-C Ptca Balloon Dilatation Catheter - 4MM X 19MM X 1 (2012), 3 descendants of its own
- K131450: Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System - 3.5MM X 8MM X 135CM, Flash Mini Ostial System - 4.0 (2013), 2 descendants of its own
- K152485: FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm (2016), 1 descendant of its own
- K254022: FLASH Flex™ Aorto-Ostial Angioplasty System (2026), 0 descendants of its own

## Indications for use
The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion.

Source page: https://510kreport.com/device/K111284
Methodology: https://510kreport.com/methodology