510(k) · Cleared

Cleared

Twin-Pass Otw Catheter, Model 5201

K072618510(k) TraditionalCleared Nov 21, 200765-day reviewClass II21 CFR 870.1250

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

Vascular Solutions, Inc. · DQY Catheter, Percutaneous

Cleared on Nov 21, 2007 as substantially equivalent to K052257 (Vascular Solutions, Inc., 2005) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 2005. 2 of the 13 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.

Decided: Nov 21, 2007
Review: 65 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K052257 (2005). 2 ancestors in all. 10 later devices descend from it, 2 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK052257 Vascular Solutions Twin-Pass Dual Access CatheterVascular Solutions, Inc. · 2005 · Recalled (Class I)
This deviceK072618 Twin-Pass Otw Catheter, Model 5201Vascular Solutions, Inc. · 2007
Descendant · cites it directly · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
Descendant · 2 generations on · 3 of its ownK140910 Centercross CatheterRoxwood Medical, Inc. · 2014
Descendant · 3 generations on · 2 of its ownK152456 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
Descendant · 2 generations on · 2 of its ownK143608 NovaCross MicrocatheterNitiloop, Ltd. · 2015
Descendant · 4 generations on · 1 of its ownK160681 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012high 4 (2016) · low 0 (2013)2026

Class I recalls in this family

K060327 Vascular Solutions Twin-Pass Dual Access…direct predicate · 2006
K052257 Vascular Solutions Twin-Pass Dual Access Catheterdirect predicate · 2005

Most influential descendants

Showing 5 of 10 · See all

K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · cites it directly8descendants
K140910Centercross CatheterRoxwood Medical, Inc. · 2014 · 2 generations on3descendants
K152456CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016 · 3 generations on2descendants
K143608NovaCross MicrocatheterNitiloop, Ltd. · 2015 · 2 generations on2descendants
K160681CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K052257	Vascular Solutions Twin-Pass Dual Access Catheter	Vascular Solutions, Inc.	2005	Class I
0 (this device)	K072618	Twin-Pass Otw Catheter, Model 5201	Vascular Solutions, Inc.	2007	—
+1	K121763	Multicross Support Catheter	Roxwood Medical, Inc.	2012	—
+2	K140910	Centercross Catheter	Roxwood Medical, Inc.	2014	—
+3	K152456	CenterCross Ultra Catheter	Roxwood Medical, Inc.	2016	—
+2	K143608	NovaCross Microcatheter	Nitiloop, Ltd.	2015	—
+4	K160681	CenterCross Ultra Catheter	Roxwood Medical, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0
2015	1	0
2016	4	0
2017	2	0
2018	1	0

FIG. 1 — Lineage of K072618, 2005–2018Source: 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.

2 devices in this family have a Class I recall. 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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
*	K052257	Vascular Solutions Twin-Pass Dual Access Catheter Summary page 1 …eous Catheter Classification Name: Unclassified Product Code: DQY Regulation: 21 CFR 870.1250 Predicate Device(s) Twin-PasSTm Dual Access Catheter (K052257) Twin-PasSTm Dual Access Catheter (K0603:27) Device Description The Vascular Solutions Twin-Pass OTW Catheter is a sterile singl…	Vascular Solutions, Inc.	2005	Class I
*	K060327	Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter Summary page 2 …verification of the Twin-Pass OTW Catheter along with biocompatibility assessments. Shelf life testing was leveraged from the Twin Pass Dual Access Catheter (K052257 and K060327). The results of this testing confirmed the suitability of the Twin-Pass OTW Catheter for its intended use. Each bench test that…	Vascular Solutions, Inc.	2006	Class I

Also cleared against K052257: 1 other device →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K121763	Multicross Support Catheter	Roxwood Medical, Inc.	2012	8
K180919	GORE Tri-Lumen Catheter	W. L. Gore and Associates, Inc.	2018	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
K052257Vascular Solutions Twin-Pass Dual Access CatheterVascular Solutions, Inc. · 2005 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K121763 (Roxwood Medical, Inc., 2012) has gone furthest, with 8 descendants of its own.
1 other device also cites its predicate K052257.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The TwinPass OTW Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072618 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072618: Twin-Pass Otw Catheter, Model 5201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072618

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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