# K083784: Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010, Skyway RX Support Catheter,

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Mar 30, 2009 after 101 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- 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: 5 generations back to K010579 (2001). 20 ancestors in all.
10 later devices descend from it; 4 cite it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063371: Pronto V3 Extraction Catheter, Model 5003, Vascular Solutions, Inc. (2006) Summary page 7.
- K072810: Pronto Low Profile (LP) Extraction Catheter, Model 5010, Vascular Solutions, Inc. (2007) Summary page 7.
- K060327: Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter, Vascular Solutions, Inc. (2006) Summary page 7.

## Most influential descendants
- K103405: Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4 Extraction 7F; Pronto V4 Extraction Cath (2010), 4 descendants of its own
- K161506: Penumbra Aspiration System (2016), 3 descendants of its own
- K163618: INDIGO Aspiration System (2017), 2 descendants of its own
- K162467: Twin-Pass Torque (2017), 2 descendants of its own
- K200324: NHancer Rx (2020), 1 descendant of its own

## Indications for use
The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SKYWAY OTW also may be used to subselectively infuse/deliver therapeutic agents. The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents. The PRONTO extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K083784
Methodology: https://510kreport.com/methodology