510(k) · Cleared

Cleared

Naviport Deflectable Tip Guiding Catheter

K974683510(k) TraditionalCleared Jun 22, 1999553-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

Cardima, Inc. · DQY Catheter, Percutaneous

Cleared on Jun 22, 1999 as substantially equivalent to K931794 (Medtronic Cardiorhythm, 1994) and 1 other predicate after a 553-day review. Its family tree reaches back 1 generation to 1994. 8 of the 122 devices in its family, counting itself, have a Class I recall. 119 later devices descend from it.

Decided: Jun 22, 1999
Review: 553 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K931794 (1994). 2 ancestors in all. 119 later devices descend from it, 6 citing it directly. 8 of the 122 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
This deviceK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
Descendant · cites it directly · 80 of its ownK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
Descendant · 2 generations on · 37 of its ownK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
Descendant · cites it directly · 37 of its ownK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
Descendant · 2 generations on · 35 of its ownK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
Descendant · 2 generations on · 31 of its ownK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)

Showing 5 of 119 descendants. See all descendants

Descendants cleared per year

1999high 9 (2006) · low 0 (2000)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
K121611 Amplatzer Torqvue FX4 generations on · 2012

Most influential descendants

Showing 5 of 119 · See all

K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002 · cites it directly80descendants
K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003 · 2 generations on37descendants
K012749Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002 · cites it directly37descendants
K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 2004 · 2 generations on35descendants
K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 2 generations on31descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931794	Marinr Series EP Diagnostic Catheters	Medtronic Cardiorhythm	1994	—
0 (this device)	K974683	Naviport Deflectable Tip Guiding Catheter	Cardima, Inc.	1999	—
+1	K013517	10600 Deflectable Catheter System, Model 10600	Medtronic Vascular	2002	—
+2	K032312	Attain 6226DEF Deflectable Catheter Delivery System	Medtronic Vascular	2003	—
+1	K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664	Biocardia, Inc.	2002	—
+2	K033989	Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69	Medtronic Inc. Cardiac Rhythm Management	2004	—
+2	K040922	Venture Wire Control Catheter	Velocimed, Inc.	2004	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	2	0
2003	4	0
2004	5	2
2005	3	0
2006	9	1
2007	3	0
2008	4	0
2009	5	0
2010	5	0
2011	5	0
2012	8	1
2013	2	0
2014	2	0
2015	3	0
2016	6	0
2017	3	0
2018	3	1
2019	6	0
2020	6	0
2021	3	1
2022	2	1
2023	6	0
2024	7	1
2025	7	0
2026	9	0

FIG. 1 — Lineage of K974683, 1994–2026Source: 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.

8 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
*	K931794	Marinr Series EP Diagnostic Catheters Summary page 2 …Equivalence: Catheýer -*s 7-_bsr_antia'1y equivalent to Medtronic's Marinrý'A Steerable Intracardiac Electrode Catheter (K931794, Decision Date 6/6/94) and Sherpa Guiding Catheter (K955651, Decision Date 1/22/9G) . Establishment of equivalence is based on si…	Medtronic Cardiorhythm	1994	—
*	K955651	Medtronic Sherpa Guiding Catheter Summary page 2 …atheýer -*s 7-_bsr_antia'1y equivalent to Medtronic's Marinrý'A Steerable Intracardiac Electrode Catheter (K931794, Decision Date 6/6/94) and Sherpa Guiding Catheter (K955651, Decision Date 1/22/9G) . Establishment of equivalence is based on similarities of intended use, design, and physical characteris…	Medtronics Interventional Vascular	1996	—

Also cleared against K931794: 6 other devices →

What descends from it? (119)

See all 119

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

Number	Device	Applicant	Decided	Descendants
K013517	10600 Deflectable Catheter System, Model 10600	Medtronic Vascular	2002	80
K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664	Biocardia, Inc.	2002	37
K031211	Attain Prevail Steerable Catheter Set, Model 6228CTH	Medtronic Vascular	2003	29
K042553	Biocardia Morph Universal Deflectable Guide Catheter	Biocardia, Inc.	2005	3
K030630	Edwards Directional Catheter	Edwards Lifesciences, LLC	2003	0
K993445	Omnisonic Endoscopic Deflector	Omnisonics Medical Technologies	1999	0

Has anything in its family been recalled? (8 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
K121611Amplatzer Torqvue FXAga Medical Corporation · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K180864WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 15 Class I recalls
K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall

Nearest 5 of 8; all are on the web page.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K013517 (Medtronic Vascular, 2002) has gone furthest, with 80 descendants of its own.
6 other devices also cite its predicate K931794.

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 NAVIPORT deflectable guiding catheter is intended to serve as a conduit for access into the chambers and coronary vasculature of the heart.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K974683 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974683: Naviport Deflectable Tip Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974683

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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