510(k) · Cleared
Cleared10600 Deflectable Catheter System, Model 10600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQY Catheter, Percutaneous
Cleared on Apr 25, 2002 as substantially equivalent to K012130 (Medtronic Vascular, 2001) and 5 other predicates after a 185-day review. Its family tree reaches back 3 generations to 1989. 5 of the 115 devices in its family, counting itself, have a Class I recall. 80 later devices descend from it.
- Decided
- Apr 25, 2002
- Review
- 185 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K893658 (1989). 34 ancestors in all, the oldest K770977 (1977). 80 later devices descend from it, 4 citing it directly. 5 of the 115 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 2 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 1 generation backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- This deviceK013517 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 · cites it directly · 35 of its ownK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
- Descendant · 2 generations on · 30 of its ownK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
- Descendant · cites it directly · 29 of its ownK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- Descendant · 2 generations on · 17 of its ownK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 80 · See all- 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 · cites it directly35descendants
- K072313Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · 2 generations on30descendants
- K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003 · cites it directly29descendants
- K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −2 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −1 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| 0 (this device) | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| +1 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| +1 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
| +2 | K072313 | Amplatzer Torqvue Delivery System | Aga Medical Corp. | 2007 | 1 |
| +1 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| +2 | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 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 |
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
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K012130 | Attain LDS 6216 Left-Heart Delivery SystemSummary page 2…55432 Medtronic Model 10600 Predicate Device - Predicate Device 510(k) Deflectable Catheter ‘ | Manufacturer Guide Catheter Model 6216 Medtronic Attain Medtronic, Inc. K012130 LDS Left-heart delivery system | Minneapolis, MN 55432 Model 6218 Medtronic Attain Medtronic, Inc. K012083 Access Left-heart deli… | 2001 |
| * | K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218Summary page 2…rer Guide Catheter Model 6216 Medtronic Attain Medtronic, Inc. K012130 LDS Left-heart delivery system | Minneapolis, MN 55432 Model 6218 Medtronic Attain Medtronic, Inc. K012083 Access Left-heart delivery Minneapolis, MN 55432 system ‘ ‘ GCIII (Vector, Vector X) Medtronic Interventional K950179 Coronary Gu… | 2001 |
| * | K950179 | Medtronic (R) GC Iii Coronary Guiding CatheterSummary page 2…N 55432 Model 6218 Medtronic Attain Medtronic, Inc. K012083 Access Left-heart delivery Minneapolis, MN 55432 system ‘ ‘ GCIII (Vector, Vector X) Medtronic Interventional K950179 Coronary Guiding Catheter Vascular (MIV) ‘ o Danvers, MA 01923 Cardima Naviport Deflectable Cardima K974683 Guiding Catheter Frem… | 1995 |
| * | K974683 | Naviport Deflectable Tip Guiding CatheterSummary page 2…system ‘ ‘ GCIII (Vector, Vector X) Medtronic Interventional K950179 Coronary Guiding Catheter Vascular (MIV) ‘ o Danvers, MA 01923 Cardima Naviport Deflectable Cardima K974683 Guiding Catheter Fremont, CA 94538 -| SafeShéath CSG (Same as Thomas Medical K003731 SafeSheath MSP) Malvern, PA 19355 Marinr Ser… | 1999 |
| * | K003731 | Safesheath MSP Introducer Sheath Kit with Integral Hemostasis ValveSummary page 2…g Catheter Vascular (MIV) ‘ o Danvers, MA 01923 Cardima Naviport Deflectable Cardima K974683 Guiding Catheter Fremont, CA 94538 -| SafeShéath CSG (Same as Thomas Medical K003731 SafeSheath MSP) Malvern, PA 19355 Marinr Series EP Diagnostic Medtronic CardioRhythm K931794 T Catheters | Minneapolis, MN 55432… | 2001 |
| * | K931794 | Marinr Series EP Diagnostic CathetersSummary page 2…Guiding Catheter Fremont, CA 94538 -| SafeShéath CSG (Same as Thomas Medical K003731 SafeSheath MSP) Malvern, PA 19355 Marinr Series EP Diagnostic Medtronic CardioRhythm K931794 T Catheters | Minneapolis, MN 55432 Guide Catheter Dilator Model 621 6 Madfroni:c Attain Medtronic, Inc. K012130 Adjustable Hemos… | 1994 |
| † | K893658 | Percutaneous Introducer | 1989 |
| † | K965167 | Percutaneous Venous Introducer 10264 | 1997 |
What descends from it? (80)
See all 804 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K180864WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 15 Class I recalls
- K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
- K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 34 ancestors have a recall of any class.
- Of its descendants, K032312 (Medtronic Vascular, 2003) has gone furthest, with 37 descendants of its own.
- 5 other devices also cite its predicate K012130.
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 deflectable catheter system 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013517: 10600 Deflectable Catheter System, Model 10600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013517
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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