510(k) · Cleared

Cleared

Model 9210 Delivery Catheter, Model 9210

K013963510(k) TraditionalCleared Feb 28, 200287-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

Medtronic Vascular · DQY Catheter, Percutaneous

Cleared on Feb 28, 2002 as substantially equivalent to K950179 (Medtronics Interventional Vascular, 1995) after an 87-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Feb 28, 2002
Review: 87 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K950179 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK950179 Medtronic (R) GC Iii Coronary Guiding CatheterMedtronics Interventional Vascular · 1995
This deviceK013963 Model 9210 Delivery Catheter, Model 9210Medtronic Vascular · 2002
Descendant · cites it directly · 0 of its ownK022620 Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36…Spire Biomedical, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all

K022620Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and XrikrtSpire Biomedical, Inc. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950179	Medtronic (R) GC Iii Coronary Guiding Catheter	Medtronics Interventional Vascular	1995	—
0 (this device)	K013963	Model 9210 Delivery Catheter, Model 9210	Medtronic Vascular	2002	—
+1	K022620	Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and…	Spire Biomedical, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K013963, 1995–2002Source: 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
*	K950179	Medtronic (R) GC Iii Coronary Guiding Catheter Summary page 2 …ronic Model 9210 catheter is substantially equivalent to the Medtronic Vector/Vector X Guide Catheter submitted under the name Medtronic GCIII Coronary Guiding Catheter (K950179, cleared 7/25/95). The Model 9210 Delivery Catheter contains two lumens; the Vector/Vector X contains one lumen. The large lumen…	Medtronics Interventional Vascular	1995	—

Also cleared against K950179: 4 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K022620	Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt	Spire Biomedical, Inc.	2002	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K022620 (Spire Biomedical, Inc., 2002) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K950179.

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 Medtronic Model 9210 Delivery Catheter is

intended for device passage and placement within the

venous vessels and chambers of the heart.

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/K013963 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013963: Model 9210 Delivery Catheter, Model 9210.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013963

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026