510(k) · Cleared

Cleared

Attain Access 6218 Left-Heart Delivery System, Model 6218

K012083510(k) TraditionalCleared Aug 28, 200156-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 Aug 28, 2001 as substantially equivalent to K950490 (Medtronics Interventional Vascular, 1995) and 6 other predicates after a 56-day review. Its family tree reaches back 2 generations to 1977. 5 of the 119 devices in its family, counting itself, have a Class I recall. 89 later devices descend from it.

Decided: Aug 28, 2001
Review: 56 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 7

Its longest line of descent runs back 2 generations to K770977 (1977). 29 ancestors in all. 89 later devices descend from it, 7 citing it directly. 5 of the 119 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK770977 Cardiovascular Spring GuidesLake Region Mfg., Inc. · 1977 · Recalled
1 generation backK963320 TFX Medical GuidewireTfx Medical Group · 1996
This deviceK012083 Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001
Descendant · cites it directly · 80 of its ownK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
Descendant · cites it directly · 37 of its ownK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
Descendant · 2 generations on · 35 of its ownK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
Descendant · cites it directly · 31 of its ownK021587 Attain LDS 6216A Left-Heart Delivery System, Model 6216AMedtronic Vascular · 2002 · Recalled
Descendant · cites it directly · 31 of its ownK021589 Attain Access 6218A Left-Heart Delivery System, Model 6218Medtronic Vascular · 2002 · Recalled

Showing 5 of 89 descendants. See all descendants

Descendants cleared per year

2002high 10 (2006) · low 0 (2014)2026

Class I recalls in this family

K121611 Amplatzer Torqvue FX4 generations on · 2012
K180864 WATCHMAN TruSeal Access System5 generations on · 2018
K212228 WATCHMAN FXD Curve Access System6 generations on · 2021
K220340 Amplatzer Steerable Delivery Sheath7 generations on · 2022

Most influential descendants

Showing 5 of 89 · See all

K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002 · cites it directly80descendants
K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003 · cites it directly37descendants
K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 2004 · 2 generations on35descendants
K021587Attain LDS 6216A Left-Heart Delivery System, Model 6216AMedtronic Vascular · 2002 · cites it directly31descendants
K021589Attain Access 6218A Left-Heart Delivery System, Model 6218Medtronic Vascular · 2002 · cites it directly31descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K770977	Cardiovascular Spring Guides	Lake Region Mfg., Inc.	1977	1
−1	K963320	TFX Medical Guidewire	Tfx Medical Group	1996	—
0 (this device)	K012083	Attain Access 6218 Left-Heart Delivery System, Model 6218	Medtronic Vascular	2001	—
+1	K013517	10600 Deflectable Catheter System, Model 10600	Medtronic Vascular	2002	—
+1	K032312	Attain 6226DEF Deflectable Catheter Delivery System	Medtronic Vascular	2003	—
+2	K033989	Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69	Medtronic Inc. Cardiac Rhythm Management	2004	—
+1	K021587	Attain LDS 6216A Left-Heart Delivery System, Model 6216A	Medtronic Vascular	2002	1
+1	K021589	Attain Access 6218A Left-Heart Delivery System, Model 6218	Medtronic Vascular	2002	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	2	0
1986	1	0
1987	3	0
1988	1	0
1989	1	0
1990	5	0
1991	1	0
1992	3	0
1993	1	0
1994	3	0
1995	3	0
1997	1	0
1999	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	4	0
2003	4	0
2004	3	0
2005	2	0
2006	10	0
2007	4	0
2008	5	0
2009	4	0
2010	4	0
2011	3	0
2012	3	1
2013	2	0
2015	1	0
2016	2	0
2018	3	1
2019	4	0
2020	3	0
2021	3	1
2022	2	1
2023	3	0
2024	5	1
2025	7	0
2026	8	0

FIG. 1 — Lineage of K012083, 1977–2026Source: 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.

5 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? (7)

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
*	K950490	Medtronic GC IV Coronary Guiding Catheter Summary page 2 …Delivery System Substantially Equivalent Devices Attain Access 6218 Left-heart Delivery System Predicate Devices T Medtronic GC IV Coronary \| Medtronic Interventional K950490 Guiding Catheter Vascular (MIV) Danvers, MA 01923 SafeSheath MSP (Same as Thomas Medical K003731 SafeSheath CSG) Malvern, PA 1935…	Medtronics Interventional Vascular	1995	—
*	K003731	Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve Summary page 2 …redicate Devices T Medtronic GC IV Coronary \| Medtronic Interventional K950490 Guiding Catheter Vascular (MIV) Danvers, MA 01923 SafeSheath MSP (Same as Thomas Medical K003731 SafeSheath CSG) Malvern, PA 19355 GC 1II (Vector, Vector X) Medtronic Interventional K950179 Coronary Guiding Catheter \| Vascular…	Thomas Medical Products, Inc.	2001	6
*	K950179	Medtronic (R) GC Iii Coronary Guiding Catheter Summary page 2 …eter Vascular (MIV) Danvers, MA 01923 SafeSheath MSP (Same as Thomas Medical K003731 SafeSheath CSG) Malvern, PA 19355 GC 1II (Vector, Vector X) Medtronic Interventional K950179 Coronary Guiding Catheter \| Vascular (MIV) Danvers, MA 01923 Zuma Guiding Catheter Medtronic Interventional K990707 Vascular (MIV…	Medtronics Interventional Vascular	1995	—
*	K990707	Medtronic 5F & 9F Zuma Guiding Catheters Summary page 2 …55 GC 1II (Vector, Vector X) Medtronic Interventional K950179 Coronary Guiding Catheter \| Vascular (MIV) Danvers, MA 01923 Zuma Guiding Catheter Medtronic Interventional K990707 Vascular (MIV) Danvers, MA 01923 Percutaneous Introducer Kit \| MedAmicus K965167 (Component) Minneapolis, MN 55447 SafeSheath MSP…	Medtronics Interventional Vascular	1999	5
*	K965167	Percutaneous Venous Introducer 10264 Summary page 2 …theter \| Vascular (MIV) Danvers, MA 01923 Zuma Guiding Catheter Medtronic Interventional K990707 Vascular (MIV) Danvers, MA 01923 Percutaneous Introducer Kit \| MedAmicus K965167 (Component) Minneapolis, MN 55447 SafeSheath MSP (Same as \| Thomas Medical K003731 SafeSheath CSG) Malvern, PA 19355 Y-Adaptor W/…	Medamicus, Inc.	1997	—
*	K895580	Y-Adapter W/Thouy Borst Summary page 2 …micus K965167 (Component) Minneapolis, MN 55447 SafeSheath MSP (Same as \| Thomas Medical K003731 SafeSheath CSG) Malvern, PA 19355 Y-Adaptor W/Touhy Borst \| Angeion Corp K895580 Valve Plymouth, MN 55441 TFX Medical Guide Wire \| TFX Medical Group K963320 Iaffrey, NH 03452 Percutaneous Introducer Kit \| MedAm…	Angeion Corp.	1990	—
*	K963320	TFX Medical Guidewire Summary page 2 …omas Medical K003731 SafeSheath CSG) Malvern, PA 19355 Y-Adaptor W/Touhy Borst \| Angeion Corp K895580 Valve Plymouth, MN 55441 TFX Medical Guide Wire \| TFX Medical Group K963320 Iaffrey, NH 03452 Percutaneous Introducer Kit \| MedAmicus K965167 \| (Component) Minneapolis, MN 55447 ! Class I device, exempt fr…	Tfx Medical Group	1996	—

Also cleared against K950490: 1 other device →

What descends from it? (89)

See all 89

7 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
K032312	Attain 6226DEF Deflectable Catheter Delivery System	Medtronic Vascular	2003	37
K021587	Attain LDS 6216A Left-Heart Delivery System, Model 6216A	Medtronic Vascular	2002	31
K021589	Attain Access 6218A Left-Heart Delivery System, Model 6218	Medtronic Vascular	2002	31
K053400	Acumen Single-Lumen Delivery Sheath	Acumen Medical, Inc.	2006	11
K052459	6248VAL Adjustable Valve	Medtronic Vascular	2006	0
K023937	Cook Vascular Serpenta Coronary Sinus Introducer System	Cook Vascular, Inc.	2003	0

Has anything in its family been recalled? (5 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.

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

What does this lineage say?

The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 19.5 years on median.
5 of the 29 ancestors have a recall of any class.
Of its descendants, K013517 (Medtronic Vascular, 2002) has gone furthest, with 80 descendants of its own.
1 other device also cites its predicate K950490.

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 Attain Access 6218 Left-heart delivery system is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

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/K012083 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012083

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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