# K072947: Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters

- Pathway: 510(k) (Traditional)
- Applicant: ClearStream Technologies, Ltd.
- Decided: Feb 8, 2008 after 113 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: 1 generation back to K042537 (2004). 1 ancestor in all.
79 later devices descend from it; 7 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042537: Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx, Invatec Innovative Technologies (2004) Summary page 1.

## Most influential descendants
- K082579: Evercross .035 Otw Pta Dilatation Catheter (2008), 35 descendants of its own
- K083919: Amphirion Deep 0.014 Otw Pta Balloon Catheter (2009), 26 descendants of its own
- K093286: Powercross .018 Otw Pta Dilation Catheter (2009), 14 descendants of its own
- K100490: Litepac, Model 682 (2010), 12 descendants of its own
- K131199: Ultraverse RX Pta Balloon Dilatation Catheter (2013), 11 descendants of its own

## Indications for use
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

Source page: https://510kreport.com/device/K072947
Methodology: https://510kreport.com/methodology