# K032763: Vascular Solutions Pronto Extraction Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Dec 19, 2003 after 105 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.
68 later devices descend from it; 8 cite it directly.
3 of 69 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) Fogarty Thru-Lumen Embolectomy Catheter: named in the summary without a submission number
- (no number) American Biomed Embolectomy Catheter: named in the summary without a submission number
- (no number) LeMaitre Embolectomy Catheter: named in the summary without a submission number

## Most influential descendants
- K040869: Export Catheter (2004), 59 descendants of its own
- K061958: Medtronic Export XT Catheter (2006), 30 descendants of its own
- K042937: Modification to Vascular Solutions Pronto Extraction Catheter (2005), 18 descendants of its own
- K050276: Diver C.E. Catheter (2005), 17 descendants of its own
- K041123: Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 (2004), 17 descendants of its own

## Recalls of this device
- May 12, 2004 · Not classified · Z-1089-04: The marker band in guidewire lumen could move from the manufactured location during clinical use.

## Indications for use
The Pronto™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The Pronto™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Source page: https://510kreport.com/device/K032763
Methodology: https://510kreport.com/methodology