510(k) · Cleared

Cleared

Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10F

K961280510(k) TraditionalCleared May 15, 199642-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

Scimed Life Systems, Inc. · DQY Catheter, Percutaneous

Cleared on May 15, 1996 after a 42-day review. The FDA summary names its predicate without a number. 3 of the 39 devices in its family, counting itself, have a Class I recall. 38 later devices descend from it.

Decided: May 15, 1996
Review: 42 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 0

38 later devices descend from it, 2 citing it directly. 3 of the 39 devices in this family, counting this one, have a Class I recall.

This deviceK961280 Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10FScimed Life Systems, Inc. · 1996
Descendant · cites it directly · 37 of its ownK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
Descendant · 2 generations on · 31 of its ownK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
Descendant · 3 generations on · 30 of its ownK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
Descendant · 4 generations on · 28 of its ownK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
Descendant · 5 generations on · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2002high 5 (2012) · low 0 (2007)2026

Class I recalls in this family

K040922 Venture Wire Control Catheter2 generations on · 2004
K042910 Venture Wire Control Catheter, Model WCC3 generations on · 2004
K061843 Venture Wire Control Catheter, Model WCC4 generations on · 2006

Most influential descendants

Showing 5 of 38 · See all

K012749Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002 · cites it directly37descendants
K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 2 generations on31descendants
K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 3 generations on30descendants
K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 4 generations on28descendants
K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · 5 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K961280	Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10F	Scimed Life Systems, Inc.	1996	—
+1	K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664	Biocardia, Inc.	2002	—
+2	K040922	Venture Wire Control Catheter	Velocimed, Inc.	2004	Class I
+3	K042910	Venture Wire Control Catheter, Model WCC	Velocimed, Inc.	2004	Class I
+4	K061843	Venture Wire Control Catheter, Model WCC	St Jude Medical	2006	Class I
+5	K080987	Bridgepoint Medical Stingray Device and Accessories	Bridgepoint Medical	2009	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	2	2
2005	1	0
2006	1	1
2009	2	0
2010	1	0
2011	2	0
2012	5	0
2014	2	0
2015	2	0
2016	4	0
2017	3	0
2019	2	0
2020	3	0
2023	3	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K961280, 1996–2026Source: 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.

3 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

Get a 510(k) Report

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
*	—	SCIMED® 6,7,8,9 and 10 French TRIGUIDE® Guide Catheters Named without a submission number			—
*	—	Cordis® Corporation Vista Brite Tip™ Guide Catheter Named without a submission number			—

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664	Biocardia, Inc.	2002	37
K042553	Biocardia Morph Universal Deflectable Guide Catheter	Biocardia, Inc.	2005	3

Has anything in its family been recalled? (3 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.

K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 4 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K012749 (Biocardia, Inc., 2002) has gone furthest, with 37 descendants of its own.

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?

The SCIMED guide catheters are designed to 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K961280 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961280: Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961280

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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