# K103405: Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4 Extraction 7F; Pronto V4 Extraction Cath

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Dec 22, 2010 after 33 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
Longest line of descent: 6 generations back to K010579 (2001). 21 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083784: Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010, Skyway RX Support Catheter,, Vascular Solutions, Inc. (2009) Summary page 5.

## Most influential descendants
- K161506: Penumbra Aspiration System (2016), 3 descendants of its own
- K163618: INDIGO Aspiration System (2017), 2 descendants of its own
- K180412: Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister (2018), 1 descendant of its own
- K220683: INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) (2022), 0 descendants of its own

## Recalls of this device
- Jul 11, 2011 · Not classified · Z-2946-2011: Vascular Solutions , Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005, 4006, 4007, 4008). Use of this defective product could lead to a ti

## Indications for use
The Pronto 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/K103405
Methodology: https://510kreport.com/methodology