510(k) Report

510(k) · Cleared

Recalled · 2006

Enpath Deflectable Catheter

K043489510(k) TraditionalCleared May 19, 2005153-day reviewClass II21 CFR 870.1250Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Enpath Medical Incorporated · DQY Catheter, Percutaneous

Cleared on May 19, 2005 as substantially equivalent to K013517 (Medtronic Vascular, 2002) after a 153-day review. Its family tree reaches back 4 generations to 1989. 13 later devices descend from it. It has been recalled 2 times.

Decided
May 19, 2005
Review
153 days
Class
Class II
Product code
DQY
Recalls
2
Predicates
1

Its longest line of descent runs back 4 generations to K893658 (1989). 35 ancestors in all, the oldest K770977 (1977). 13 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1999: 2 other ancestors1995: 3 other ancestors1994: 4 other ancestors1996: 2 other ancestors1990: 5 other ancestors1993: 1 other ancestor1992: 3 other ancestors1991: 1 other ancestor1988: 1 other ancestor1987: 3 other ancestors1986: 1 other ancestor1985: 2 other ancestors1977: 1 other ancestor2009: 1 descendant cleared2010: 2 descendants cleared2006: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2024: 2 descendants cleared2025: 1 descendant cleared2026: 3 descendants clearedK893658 · Percutaneous Introducer · Medamicus, Inc. · 1989K965167 · Percutaneous Venous Introducer 10264 · Medamicus, Inc. · 1997K012130 · Attain LDS 6216 Left-Heart Delivery System · Medtronic Vascular · 2001K013517 · 10600 Deflectable Catheter System, Model 10600 · Medtronic Vascular · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 5 other ancestors3 generations back: 5 other ancestors4 generations back: 21 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 2 descendants8 generations forward: 1 descendant K013517 · 10600 Deflectable Catheter System, Model 10600 · Medtronic Vascular · 2002K012130 · Attain LDS 6216 Left-Heart Delivery System · Medtronic Vascular · 2001K965167 · Percutaneous Venous Introducer 10264 · Medamicus, Inc. · 1997K893658 · Percutaneous Introducer · Medamicus, Inc. · 19890+5
  1. Root · 4 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
  2. 3 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
  3. 2 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
  4. 1 generation backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
  5. This deviceK043489 Enpath Deflectable CatheterEnpath Medical Incorporated · 2005
  6. Descendant · cites it directly · 10 of its ownK061119 Enpath Medical Steerable SheathEnpath Medical, Inc. · 2006
  7. Descendant · 2 generations on · 7 of its ownK122960 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
  8. Descendant · 3 generations on · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
  9. Descendant · 4 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
  10. Descendant · 5 generations on · 4 of its ownK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12010: 22011: 12012: 12015: 12024: 22025: 12026: 3
2006high 3 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 13 · See all
  • K061119Enpath Medical Steerable SheathEnpath Medical, Inc. · 2006 · cites it directly10descendants
  • K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · 2 generations on7descendants
  • K151951Destino ReachOscor, Inc. · 2015 · 3 generations on6descendants
  • K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 4 generations on5descendants
  • K242106AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 5 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K893658Percutaneous IntroducerMedamicus, Inc.1989—
−3K965167Percutaneous Venous Introducer 10264Medamicus, Inc.1997—
−2K012130Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular2001—
−1K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular2002—
0 (this device)K043489Enpath Deflectable CatheterEnpath Medical Incorporated2005—
+1K061119Enpath Medical Steerable SheathEnpath Medical, Inc.2006—
+2K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.2012—
+3K151951Destino ReachOscor, Inc.2015—
+4K240829AuST Steerable SheathCenterPoint Systems, LLC2024—
+5K242106AuST Steerable SheathCenterPoint Systems, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
198520
198610
198730
198810
199050
199110
199230
199310
199440
199530
199620
199920
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201020
201110
201210
201510
202420
202510
202630
FIG. 1 — Lineage of K043489, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K01351710600 Deflectable Catheter System, Model 10600
Summary page 1
…entional devices into the peripheral and coronary systems. Predicate Device * Medtronic, Inc: Medtronic Model 10600 Deflectable Catheter System 510(k) K013517 Device Description The Enpath Deflectable Catheter is a guide catheter (delivery sheath) which has a distal tip that…
Medtronic Vascular2002—

Also cleared against K013517: 3 other devices →

What descends from it? (13)

See all 13

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061119Enpath Medical Steerable SheathEnpath Medical, Inc.200610
K100135GDS-DC12Guided Delivery Systems20100
K090999Biocardia Morph Sheath GuideBiocardia, Inc.20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 27, 2006Not classifiedZ-0118-2007OtherEnpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.
Aug 31, 2005Not classifiedZ-1573-05OtherEnpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
  • 5 of the 35 ancestors have a recall of any class.
  • Of its descendants, K061119 (Enpath Medical, Inc., 2006) has gone furthest, with 10 descendants of its own.
  • 3 other devices also cite its predicate K013517.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The Enpath Deflectable Catheter 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.

Also cleared against K013517

3 other devices cite the same predicate.

  • K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 2004
  • K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
  • K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003

More from Enpath Medical Incorporated

2 FDA decisions under this applicant name. See the company

  • K041708Enpath Safety IntroducerEnpath Medical Incorporated · 2004

Recent decisions in DQY

The DQY category page

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  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K043489 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043489: Enpath Deflectable Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043489

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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