510(k) · Cleared
Recalled · Class II · 2021Medtronic C315 Delivery Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DQY Catheter, Percutaneous
Cleared on Sep 9, 2010 as substantially equivalent to K080500 (Acumen Medical, Inc., 2008) and 1 other predicate after a 65-day review. Its family tree reaches back 9 generations to 1989. 8 later devices descend from it. It has been recalled once.
- Decided
- Sep 9, 2010
- Review
- 65 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K893658 (1989). 56 ancestors in all, the oldest K760385 (1976). 8 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 5 generations between
- 3 generations backK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- 2 generations backK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- 1 generation backK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- This deviceK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK190475 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter…Centerpoint Systems · 2019
- Descendant · 2 generations on · 3 of its ownK230363 CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC · 2023
- Descendant · 3 generations on · 1 of its ownK250828 CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2025
- Descendant · cites it directly · 1 of its ownK192712 Attain Select II + SureValve delivery catheter system, Attain…Medtronic, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK261766 CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
Show all 9 generations
- Root · 9 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 8 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 7 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 6 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 5 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 4 generations backK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
- 3 generations backK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- 2 generations backK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- 1 generation backK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- This deviceK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems · 2019 · cites it directly5descendants
- K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC · 2023 · 2 generations on3descendants
- K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2025 · 3 generations on1descendant
- K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc. · 2020 · cites it directly1descendant
- K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −8 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −7 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −6 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −5 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −4 | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | — |
| −3 | 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 | — |
| −1 | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left… | Medtronic, Inc. | 2009 | — |
| 0 (this device) | K101885 | Medtronic C315 Delivery Catheter | Medtronic, Inc. | 2010 | — |
| +1 | K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3… | Centerpoint Systems | 2019 | — |
| +2 | K230363 | CPS Locator 3D Delivery Catheter | CenterPoint Systems, LLC | 2023 | — |
| +3 | K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025 | — |
| +1 | K192712 | Attain Select II + SureValve delivery catheter system, Attain Command +… | Medtronic, Inc. | 2020 | — |
| +4 | K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026 | — |
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 | 6 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K080500 | Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7Summary page 2…l to the predicate Acumen Single Lumen Delivery Sheath (510(1k) cleared K080500). Substantially Equivalent The Medtronic C3 15 Delivery Catheter product family uses similar lDeviccs:… | 2008 |
| * | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Summary page 2…Delivery Sheath (510(k) 1(080500) and Attain Comrnandr 6250 product famnily (510(1k) K090659). Summary of Technological The Medtronic C315 Delivery Catheter consists of a hydrophilic Characteris… | 2009 |
What descends from it? (8)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2021 | Class II | Z-0173-2022 | Under Investigation by firm | Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 10 of the 56 ancestors have a recall of any class.
- Of its descendants, K190475 (Centerpoint Systems, 2019) has gone furthest, with 5 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. 2010, 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 C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101885 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101885: Medtronic C315 Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101885
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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