510(k) · Cleared

Recalled · Class II · 2009

Diver C.E. Catheter

K050276510(k) TraditionalCleared Mar 7, 200528-day reviewClass II21 CFR 870.5150Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Invatec Innovative Technologies, S.R.L. · QEZ Aspiration Thrombectomy Catheter

Cleared on Mar 7, 2005 as substantially equivalent to K032763 (Vascular Solutions, Inc., 2003) and 2 other predicates after a 28-day review. Its family tree reaches back 1 generation to 2003. 17 later devices descend from it. It has been recalled once.

Decided: Mar 7, 2005
Review: 28 days
Class: Class II
Product code: QEZ
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K032763 (2003). 3 ancestors in all. 17 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK032763 Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2003 · Recalled
This deviceK050276 Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005
Descendant · cites it directly · 13 of its ownK051917 Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005 · Recalled
Descendant · cites it directly · 12 of its ownK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
Descendant · 2 generations on · 11 of its ownK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
Descendant · 3 generations on · 10 of its ownK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
Descendant · 4 generations on · 4 of its ownK103405 Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter…Vascular Solutions, Inc. · 2010 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2005high 3 (2009) · low 0 (2012)2026

Most influential descendants

Showing 5 of 17 · See all

K051917Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005 · cites it directly13descendants
K071727QXT Extraction CatheterVascular Solutions, Inc. · 2007 · cites it directly12descendants
K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007 · 2 generations on11descendants
K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc. · 2009 · 3 generations on10descendants
K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc. · 2010 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032763	Vascular Solutions Pronto Extraction Catheter	Vascular Solutions, Inc.	2003	1
0 (this device)	K050276	Diver C.E. Catheter	Invatec Innovative Technologies, S.R.L.	2005	—
+1	K051917	Diver C.E. Catheter	Invatec Innovative Technologies, S.R.L.	2005	1
+1	K071727	QXT Extraction Catheter	Vascular Solutions, Inc.	2007	—
+2	K072810	Pronto Low Profile (LP) Extraction Catheter, Model 5010	Vascular Solutions, Inc.	2007	—
+3	K083784	Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model…	Vascular Solutions, Inc.	2009	—
+4	K103405	Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto…	Vascular Solutions, Inc.	2010	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2007	2	0
2008	1	0
2009	3	0
2010	1	0
2011	1	0
2016	1	0
2017	2	0
2018	1	0
2020	1	0
2021	1	0
2022	1	0

FIG. 1 — Lineage of K050276, 2003–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QEZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QEZ device

#1 K253925 Aventus Thrombectomy Systemscore 17.9 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K032763	Vascular Solutions Pronto Extraction Catheter Summary page 5 …[email protected] February 4, 2005 DIVER™ C.E. Catheter Catheter, Embolectomy Catheter, Embolectomy Class I1, 21 CFR 870.5150 Vascular Solutions Pronto™ Extraction Catheter (K032763) Invatec Innovative Technologies SUBMARINE PLUS™ PTA Catheter (K042537) Invatec Innovative Technologies AMPHIRION DEEP PTA Ball…	Vascular Solutions, Inc.	2003	1
*	K042537	Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx Summary page 5 …Catheter, Embolectomy Class I1, 21 CFR 870.5150 Vascular Solutions Pronto™ Extraction Catheter (K032763) Invatec Innovative Technologies SUBMARINE PLUS™ PTA Catheter (K042537) Invatec Innovative Technologies AMPHIRION DEEP PTA Balloon Catheter (K042624) Page 1 of 2 Device Description:…	Invatec Innovative Technologies	2004	—
*	K042624	Amphirion Deep 0.014 Otw Pta Balloon Catheter Summary page 5 …raction Catheter (K032763) Invatec Innovative Technologies SUBMARINE PLUS™ PTA Catheter (K042537) Invatec Innovative Technologies AMPHIRION DEEP PTA Balloon Catheter (K042624) Page 1 of 2 Device Description: The DIVER C.E. Catheters are aspiration catheters indicated for the removal of…	Invatec Innovative Technologies, S.R.L.	2005	1

Also cleared against K032763: 7 other devices →

What descends from it? (17)

See all 17

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051917	Diver C.E. Catheter	Invatec Innovative Technologies, S.R.L.	2005	13
K071727	QXT Extraction Catheter	Vascular Solutions, Inc.	2007	12
K060092	Quickcat Extraction Catheter	Kensey Nash Corp.	2006	2

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 4, 2009	Class II	Z-1517-2013	Labeling False and Misleading	Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K051917 (Invatec Innovative Technologies, S.R.L., 2005) has gone furthest, with 13 descendants of its own.
7 other devices also cite its predicate K032763.

How does its category compare?

All QEZ devices

QEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QEZ

5in 2025

2007high 11 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEZ

108in 2025

2007high 144 (2013) · low 33 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEZ

No recall names QEZ since 2007.

Adverse event reports per year · QEZ

21in 2025

2007high 21 (2025) · low 0 (2007)2025

MAUDE reports naming product code QEZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	11	79	0
2008	6	72	0
2009	4	83	0
2010	3	33	0
2011	7	118	0
2012	5	90	0
2013	4	144	0
2014	1	—	0
2015	0	—	0
2016	1	—	0
2017	3	112	0
2018	1	—	0
2019	3	94	0
2020	3	120	0
2021	3	53	2
2022	2	—	18
2023	1	—	14
2024	1	—	17
2025	5	108	21
2026	6	98	—

What is it indicated for?

The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and

thrombi from vessels in the arterial system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K050276 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050276: Diver C.E. Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050276

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026