# K050276: Diver C.E. Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Invatec Innovative Technologies, S.R.L.
- Decided: Mar 7, 2005 after 28 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: 1 generation back to K032763 (2003). 3 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032763: Vascular Solutions Pronto Extraction Catheter, Vascular Solutions, Inc. (2003) Summary page 5.
- K042537: Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx, Invatec Innovative Technologies (2004) Summary page 5.
- K042624: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 5.

## Most influential descendants
- K051917: Diver C.E. Catheter (2005), 13 descendants of its own
- K071727: QXT Extraction Catheter (2007), 12 descendants of its own
- 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
- 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

## Recalls of this device
- Mar 4, 2009 · Class II · Z-1517-2013: Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.

## Indications for use
The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Source page: https://510kreport.com/device/K050276
Methodology: https://510kreport.com/methodology