510(k) · Cleared
ClearedAttain Select 6238TEL Guide Catheter Set for Left-Heart Delivery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQY Catheter, Percutaneous
Cleared on Sep 15, 2004 as substantially equivalent to K021589 (Medtronic Vascular, 2002) and 2 other predicates after a 34-day review. Its family tree reaches back 5 generations to 1989. 17 later devices descend from it.
- Decided
- Sep 15, 2004
- Review
- 34 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K893658 (1989). 46 ancestors in all, the oldest K760385 (1976). 17 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 4 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 3 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 2 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 1 generation backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- This deviceK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
- Descendant · cites it directly · 14 of its ownK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- Descendant · 2 generations on · 13 of its ownK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- Descendant · 3 generations on · 12 of its ownK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- Descendant · 4 generations on · 8 of its ownK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
- Descendant · 5 generations on · 5 of its ownK190475 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter…Centerpoint Systems · 2019
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006 · cites it directly14descendants
- K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc. · 2008 · 2 generations on13descendants
- K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc. · 2009 · 3 generations on12descendants
- K101885Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · 4 generations on8descendants
- K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems · 2019 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −4 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −3 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −2 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −1 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| 0 (this device) | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | — |
| +1 | K053431 | Attain Select II 6248DEL Delivery Catheter System | Medtronic, Ireland | 2006 | — |
| +2 | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide… | Medtronic, Inc. | 2008 | — |
| +3 | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left… | Medtronic, Inc. | 2009 | — |
| +4 | K101885 | Medtronic C315 Delivery Catheter | Medtronic, Inc. | 2010 | 1 |
| +5 | K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3… | Centerpoint Systems | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K021589 | Attain Access 6218A Left-Heart Delivery System, Model 6218Summary page 2…lar intended uses, function, materials and method of operation to the following predicate devices: * Medtronic AttainTM Access 6218A Left-Heart Delivery System (K#021589, cleared May 30, 2002) · Attain TM Prevail ® Steerable Catheter Set, Model 6228CTH (K03121 1, cleared July… | 2002 |
| * | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTHSummary page 2…Medtronic AttainTM Access 6218A Left-Heart Delivery System (K#021589, cleared May 30, 2002) · Attain TM Prevail ® Steerable Catheter Set, Model 6228CTH (K03121 1, cleared July 17, 2003) * Guidant RAPIDO Tm Guiding Catheter (K#021455, cleared August 2, 2002) Summary of Studies… | 2003 |
| * | K021455 | Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777…Summary page 2…d May 30, 2002) · Attain TM Prevail ® Steerable Catheter Set, Model 6228CTH (K03121 1, cleared July 17, 2003) * Guidant RAPIDO Tm Guiding Catheter (K#021455, cleared August 2, 2002) Summary of Studies: Device integrity testing was performed to support the equivalency of the Attain Sel… | 2002 |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 9 of the 46 ancestors have a recall of any class.
- Of its descendants, K053431 (Medtronic, Ireland, 2006) has gone furthest, with 14 descendants of its own.
- 7 other devices also cite its predicate K021589.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 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 SelectTM 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042194: Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042194
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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