510(k) · Cleared

Recalled · Class II · 2014

Boston Scientific 6F Runway Guide Catheter

K033441510(k) SpecialCleared Nov 21, 200323-day reviewClass II21 CFR 870.1250Recalls 2

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

Boston Scientific Corp · DQY Catheter, Percutaneous

Cleared on Nov 21, 2003 as substantially equivalent to K010874 (Boston Scientific Corp, 2001) after a 23-day review. Its family tree reaches back 1 generation to 2001. 26 later devices descend from it. It has been recalled 2 times.

Decided: Nov 21, 2003
Review: 23 days
Class: Class II
Product code: DQY
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K010874 (2001). 26 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010874 6F Mach 1, Model 34356-XXXBoston Scientific Corp · 2001 · Recalled
This deviceK033441 Boston Scientific 6F Runway Guide CatheterBoston Scientific Corp · 2003
Descendant · cites it directly · 25 of its ownK041151 Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc. · 2004
Descendant · 2 generations on · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
Descendant · 3 generations on · 14 of its ownK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
Descendant · 3 generations on · 11 of its ownK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
Descendant · 3 generations on · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2004high 5 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 26 · See all

K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc. · 2004 · cites it directly25descendants
K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · 2 generations on24descendants
K101591Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · 3 generations on14descendants
K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · 3 generations on11descendants
K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · 3 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010874	6F Mach 1, Model 34356-XXX	Boston Scientific Corp	2001	11
0 (this device)	K033441	Boston Scientific 6F Runway Guide Catheter	Boston Scientific Corp	2003	—
+1	K041151	Kerberos Occluding Guide Catheter and Accessories	Kerberos Proximal Solutions, Inc.	2004	—
+2	K080987	Bridgepoint Medical Stingray Device and Accessories	Bridgepoint Medical	2009	1
+3	K101591	Stingray Orienting Balloon Catheter	Bridgepoint Medical	2010	1
+3	K102725	Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model…	Bridge Medical, Inc.	2011	1
+3	K121763	Multicross Support Catheter	Roxwood Medical, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2009	1	0
2010	1	0
2011	2	0
2012	5	0
2014	2	0
2015	2	0
2016	4	0
2017	2	0
2019	1	0
2020	2	0
2023	2	0
2026	1	0

FIG. 1 — Lineage of K033441, 2001–2026Source: 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 DQY? 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? (1)

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
*	K010874	6F Mach 1, Model 34356-XXX Summary page 1 …October 28,2003 6.2 Name of Predicate Device 6F Mach1 Guide Catheter K010874, June 21,2001 6.3 Device Description The Boston Scientific 6F Runway Guide Catheters are similar to the currently marketed 6…	Boston Scientific Corp	2001	11

Also cleared against K010874: 2 other devices →

What descends from it? (26)

See all 26

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041151	Kerberos Occluding Guide Catheter and Accessories	Kerberos Proximal Solutions, Inc.	2004	25

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 3, 2014	Class II	Z-1164-2014	Packaging	The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require…
Oct 29, 2004	Not classified	Z-0454-05	Other	The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K041151 (Kerberos Proximal Solutions, Inc., 2004) has gone furthest, with 25 descendants of its own.
2 other devices also cite its predicate K010874.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Boston Scientific Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033441 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033441: Boston Scientific 6F Runway Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033441

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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