# K070403: Pronto .035 Extraction Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jun 13, 2007 after 121 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: 1 generation back to K970657 (1997). 3 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051193: Vascular Solutions Pronto Short Extraction Catheter, Vascular Solutions, Inc. (2005) Summary page 5.
- K970657: Lmi Thrombectomy Catheter, Lucas Medical, Inc. (1997) Summary page 5.
- K992934: Lemaitre Venous Thrombectomy Catheter, Vascutech, Inc. (2000) Summary page 5.
- (no number) Edwards Lifesciences Fogarty Venous Thrombectomy Catheter: named in the summary without a submission number

## Most influential descendants
- K110315: Nexgen Peripheral Mechanical Retrieval Device (2011), 6 descendants of its own
- K192814: Pounce Thrombus Retrieval System (2020), 5 descendants of its own
- K211492: Pounce Thrombectomy System (2021), 4 descendants of its own
- K220501: Pounce Thrombectomy System (2022), 3 descendants of its own
- K231022: Pounce™ Thrombectomy System (2023), 2 descendants of its own

## Indications for use
The Pronto .035” extraction catheter is indicated for: The removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system. The removal/aspiration of embolic material (thrombus/debris) from vessels of the deep venous system. To infuse/deliver diagnostic or therapeutic agents.

Source page: https://510kreport.com/device/K070403
Methodology: https://510kreport.com/methodology