510(k) · Cleared
Recalled · Class II · 2022SelectSite C304-HIS Deflectable Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DQY Catheter, Percutaneous
Cleared on Mar 15, 2019 as substantially equivalent to K033989 (Medtronic Inc. Cardiac Rhythm Management, 2004) and 1 other predicate after an 88-day review. Its family tree reaches back 7 generations to 1989. It has been recalled once.
- Decided
- Mar 15, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K893658 (1989). 39 ancestors in all, the oldest K770977 (1977). No later device cites it as a predicate yet.
- Root · 7 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 6 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 5 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 4 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 3 generations backK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- 2 generations backK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
- 1 generation backK061416 Selectsite C304 Deflectable Catheter System, Models C304-S59…Medtronic Vascular · 2006
- This deviceK183493 SelectSite C304-HIS Deflectable Catheter SystemMedtronic, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −6 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −5 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −4 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −3 | 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 | K061416 | Selectsite C304 Deflectable Catheter System, Models C304-S59, C304-L69… | Medtronic Vascular | 2006 | — |
| 0 (this device) | K183493 | SelectSite C304-HIS Deflectable Catheter System | Medtronic, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 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? (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 | Decided |
|---|---|---|---|
| * | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Summary page 5…ed uses, function, materials and method of operation to the following predicate device: x SelectSite™ C304-S5901 and C304-L6901 Deflectable Catheter Systems (K033989, cleared January 22, 2004 and K061416, cleared October 26, 2006) The SelectSite™ C304HIS Catheter System is similar in shape to t… | 2004 |
| * | K061416 | Selectsite C304 Deflectable Catheter System, Models C304-S59, C304-L69, C304-XS59 &…Summary page 5…d of operation to the following predicate device: x SelectSite™ C304-S5901 and C304-L6901 Deflectable Catheter Systems (K033989, cleared January 22, 2004 and K061416, cleared October 26, 2006) The SelectSite™ C304HIS Catheter System is similar in shape to the following reference device: C315 De… | 2006 |
| † | K101885 | Medtronic C315 Delivery Catheter | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2022 | Class II | Z-1206-2022 | Under Investigation by firm | The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 39 ancestors have a recall of any class.
- 4 other devices also cite its predicate K033989.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 device is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183493: SelectSite C304-HIS Deflectable Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183493
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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