# K101047: Pta-Duo Pta Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Hotspur Technologies
- Decided: Jul 13, 2010 after 90 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K014212 (2002). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073472: Vaccess Pta Balloon Dilatation Catheter, C.R. Bard, Inc. (2008) Summary page 1.

## Most influential descendants
- K113769: Gpscath Ballon Dilatation Catheter (2012), 4 descendants of its own
- K130397: Arrow Gpscath Balloon Dilatation Catheter (2013), 3 descendants of its own
- K151678: Chameleon PTA Balloon Catheter (2015), 2 descendants of its own
- K163231: Chameleon PTA Balloon Catheter (2017), 1 descendant of its own
- K170635: Chameleon PTA Balloon Catheter (2017), 0 descendants of its own

## Indications for use
The PTA-Duo PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This Catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K101047
Methodology: https://510kreport.com/methodology