# K100842: Pta-Plus Pta Balloon Cather 5 MM X 4CM, Pta-Plus Pta Balloon Catheter 6MM X 4CM

- Pathway: 510(k) (Traditional)
- Applicant: Hotspur Technologies
- Decided: Jul 12, 2010 after 109 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- 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). 3 ancestors in all.
2 later devices descend 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)
- K901625: Fogarty Arterial Embolectomy II Catheter, Baxter Healthcare Corp (1990) Summary page 1.
- K073472: Vaccess Pta Balloon Dilatation Catheter, C.R. Bard, Inc. (2008) Summary page 1.

## Most influential descendants
- K223613: InThrill Thrombectomy System (2023), 1 descendant of its own
- K250421: InThrill™ Thrombectomy System (2025), 0 descendants of its own

## Indications for use
The PTA-Plus PTA Balloon Catheter is indicated for use within synthetic arteriovenous dialysis fistulae to remove embolic material (thrombus/debris) and dilate stenosis for treatment of obstructive lesions.

Source page: https://510kreport.com/device/K100842
Methodology: https://510kreport.com/methodology