510(k) · Cleared
ClearedEnpath Medical Steerable Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enpath Medical, Inc. · DQY Catheter, Percutaneous
Cleared on May 18, 2006 as substantially equivalent to K043489 (Enpath Medical Incorporated, 2005) after a 27-day review. Its family tree reaches back 5 generations to 1989. 10 later devices descend from it.
- Decided
- May 18, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K893658 (1989). 36 ancestors in all, the oldest K770977 (1977). 10 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 backK043489 Enpath Deflectable CatheterEnpath Medical Incorporated · 2005 · Recalled
- This deviceK061119 Enpath Medical Steerable SheathEnpath Medical, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK122960 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
- Descendant · 3 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- Descendant · 4 generations on · 4 of its ownK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- Descendant · 5 generations on · 3 of its ownK251051 AuST Steerable SheathCenterPoint Systems, LLC · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · cites it directly7descendants
- K151951Destino ReachOscor, Inc. · 2015 · 2 generations on6descendants
- K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 3 generations on5descendants
- K242106AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 4 generations on4descendants
- K251051AuST Steerable SheathCenterPoint Systems, LLC · 2025 · 5 generations on3descendants
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 | K043489 | Enpath Deflectable Catheter | Enpath Medical Incorporated | 2005 | 2 |
| 0 (this device) | K061119 | Enpath Medical Steerable Sheath | Enpath Medical, Inc. | 2006 | — |
| +1 | K122960 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | — |
| +2 | K151951 | Destino Reach | Oscor, Inc. | 2015 | — |
| +3 | K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
| +4 | K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
| +5 | K251051 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2025 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K043489 | Enpath Deflectable CatheterSummary page 1…eter Introducer ClassificationName Percutaneous Catheter (21 CFR 870.1250, Product Code DQY) Predicate Device Enpath Medical Steerable Sheath; K043489. Device Description The Enpath Steerable Sheath is a guide catheter (delivery sheath) which has a distal tip th… | 2005 |
What descends from it? (10)
3 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 17 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 6 of the 36 ancestors have a recall of any class.
- Of its descendants, K122960 (Oscor, Inc., 2012) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K043489.
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 Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061119: Enpath Medical Steerable Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061119
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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