# K051193: Vascular Solutions Pronto Short Extraction Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Aug 8, 2005 after 90 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
34 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis 7Fr Hydrolyser Thrombectomy Catheter: named in the summary without a submission number
- (no number) XTD Thrombectomy Catheter: named in the summary without a submission number
- (no number) Medtronic Export Aspiration Catheter: named in the summary without a submission number
- (no number) Vascular Solutions, Inc. Pronto Extraction Catheter: named in the summary without a submission number

## Most influential descendants
- K072810: Pronto Low Profile (LP) Extraction Catheter, Model 5010 (2007), 11 descendants of its own
- K083784: Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010, Skyway RX Support Catheter, (2009), 10 descendants of its own
- K070403: Pronto .035 Extraction Catheter (2007), 10 descendants of its own
- K053372: Lbi Catheter System (2006), 10 descendants of its own
- K071529: Xtract Catheter System (2007), 9 descendants of its own

## Recalls of this device
- Nov 20, 2009 · Not classified · Z-0547-2010: It was found that three Pronto Short (model 5030) device lots were manufactured and labeled with an expiration date which is inconsistent than the expiration of the included guidewire component. The g

## Indications for use
The Pronto™ Short Extraction Catheter is indicated for: * the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system. * the removal/aspiration of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas. The Pronto™ Short Extraction Catheter is indicated for: * the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system. * the removal/aspiration of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

Source page: https://510kreport.com/device/K051193
Methodology: https://510kreport.com/methodology