510(k) · Cleared
ClearedAttain 6218A-AM Amplatz Guide Catheter 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 Dec 30, 2002 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- Dec 30, 2002
- Review
- 24 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly.
- This deviceK024035 Attain 6218A-AM Amplatz Guide Catheter for Left-Heart DeliveryMedtronic Vascular · 2002
- Descendant · cites it directly · 13 of its ownK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- Descendant · 2 generations on · 12 of its ownK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- Descendant · 3 generations on · 8 of its ownK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 5 of its ownK190475 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter…Centerpoint Systems · 2019
- Descendant · cites it directly · 5 of its ownK031459 Rapido Cut-Away CutterGuidant Corp. · 2003 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc. · 2008 · cites it directly13descendants
- K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc. · 2009 · 2 generations on12descendants
- K101885Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · 3 generations on8descendants
- K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems · 2019 · 4 generations on5descendants
- K031459Rapido Cut-Away CutterGuidant Corp. · 2003 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024035 | Attain 6218A-AM Amplatz Guide Catheter for Left-Heart Delivery | Medtronic Vascular | 2002 | — |
| +1 | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide… | Medtronic, Inc. | 2008 | — |
| +2 | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left… | Medtronic, Inc. | 2009 | — |
| +3 | K101885 | Medtronic C315 Delivery Catheter | Medtronic, Inc. | 2010 | 1 |
| +4 | K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3… | Centerpoint Systems | 2019 | — |
| +1 | K031459 | Rapido Cut-Away Cutter | Guidant Corp. | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 203 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?
- Of its descendants, K080428 (Medtronic, Inc., 2008) has gone furthest, with 13 descendants of its own.
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) | — |
https://510kreport.com/device/K024035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024035: Attain 6218A-AM Amplatz Guide Catheter 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/K024035
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026