# K133998: Angiosculpt Pta Scoring Balloon with Hydrocross Caoting

- Pathway: 510(k) (Traditional)
- Applicant: Angioscore, Inc.
- Decided: Apr 18, 2014 after 113 days
- Product code: PNO (Catheter, Percutaneous, Cutting/Scoring)
- 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: 11 generations back to K971448 (1997). 43 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112182: Angiosculpt Pta Scoring Balloon Catheter, Angioscore, Inc. (2011) Summary page 4.
- K122685: Angiosculpt Pta Scoring Balloon Catheter, Angioscore, Inc. (2013) Summary page 4.
- K103459: Vascutrak Pta Dilatation Catheter, C.R. Bard, Inc. (2010). Our OCR of the scanned summary read K013459, FDA’s number for Modification of NC-Stat (Neurometrix, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “VascuTrak® PTA Dilatation Catheter”.

## Most influential descendants
- K142983: AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating (2015), 16 descendants of its own
- K161384: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (2016), 13 descendants of its own
- K163306: Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable (2016), 10 descendants of its own
- K150634: AngioSculpt PTA Scoring Baloon Catheters (2015), 6 descendants of its own
- K180958: Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable (2018), 4 descendants of its own

## Indications for use
The AngioSculpt PTA Scoring Balloon Catheter I8 intended for dilatation of lesions in the ‘lliac, femoral, ilto-femnoral, popliteal, infra poptiteal, and renal arteries, and for the treatment of obstructive leslons of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or néuro-vasculature.

Source page: https://510kreport.com/device/K133998
Methodology: https://510kreport.com/methodology