510(k) Report

510(k) · Cleared

Cleared

Lexiconture Mechanical Dilator Sheath Set

K140047510(k) TraditionalCleared Apr 9, 201490-day reviewClass II21 CFR 870.1310

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

Spectranetics Corp. · DRE Dilator, Vessel, For Percutaneous Catheterization

Cleared on Apr 9, 2014 as substantially equivalent to K061000 (Cook Vascular, Inc., 2006) after a 90-day review. Its family tree reaches back 1 generation to 2006. 7 later devices descend from it.

Decided
Apr 9, 2014
Review
90 days
Class
Class II
Product code
DRE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K061000 (2006). 7 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2022: 3 descendants cleared2015: 1 descendant cleared2016: 1 descendant clearedK061000 · Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 · Cook Vascular, Inc. · 200620052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K061000 · Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 · Cook Vascular, Inc. · 20060
  1. Root · 1 generation backK061000 Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Cook Vascular, Inc. · 2006
  2. This deviceK140047 Lexiconture Mechanical Dilator Sheath SetSpectranetics Corp. · 2014
  3. Descendant · cites it directly · 6 of its ownK141131 Tightrail MiniSpectranetics, Inc. · 2014
  4. Descendant · cites it directly · 5 of its ownK142546 TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc. · 2014
  5. Descendant · 2 generations on · 3 of its ownK150360 TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator…Spectranetics, Inc. · 2015
  6. Descendant · 2 generations on · 2 of its ownK161333 TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. · 2016
  7. Descendant · 3 generations on · 1 of its ownK212784 TightRail Guardian Motorized Dilator SheathSpectranetics, Inc. · 2022

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2014: 22015: 12016: 12022: 3
2014high 3 (2022) · low 0 (2017)2026

Most influential descendants

Showing 5 of 7 · See all
  • K141131Tightrail MiniSpectranetics, Inc. · 2014 · cites it directly6descendants
  • K142546TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc. · 2014 · cites it directly5descendants
  • K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathSpectranetics, Inc. · 2015 · 2 generations on3descendants
  • K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. · 2016 · 2 generations on2descendants
  • K212784TightRail Guardian Motorized Dilator SheathSpectranetics, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K061000Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Cook Vascular, Inc.2006—
0 (this device)K140047Lexiconture Mechanical Dilator Sheath SetSpectranetics Corp.2014—
+1K141131Tightrail MiniSpectranetics, Inc.2014—
+1K142546TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc.2014—
+2K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathSpectranetics, Inc.2015—
+2K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc.2016—
+3K212784TightRail Guardian Motorized Dilator SheathSpectranetics, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201510
201610
202230
FIG. 1 — Lineage of K140047, 2006–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DRE? 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 DRE device

  1. #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 2 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
*K061000Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0
Summary page 1
…Predicate Device The TightRail Mechanical Dilator Sheath Sets were compared to the following legally marketed predicate device: 510(k) Number: K061000 (cleared on May 10, 2006) Manufacturer: Cook®l Medical Trade Name: Evolution®…
Cook Vascular, Inc.2006—

Also cleared against K061000: 2 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K141131Tightrail MiniSpectranetics, Inc.20146
K142546TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc.20145
K211679Xtractor deviceXcardia Innovation, Ltd.20220

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?

  • Its one ancestor has no recall.
  • Of its descendants, K141131 (Spectranetics, Inc., 2014) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K061000.

How does its category compare?

All DRE devices

DRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · DRE

3in 2025

2007: 52008: 22009: 22010: 12011: 12012: 12013: 42014: 62015: 42016: 32017: 42018: 22019: 32020: 32021: 12022: 32023: 22024: 12025: 32026 (partial year): 1
2007high 6 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRE

31in 2025

2007: 160 days median2013: 111 days median2014: 72 days median2015: 30 days median2016: 90 days median2017: 108 days median2019: 68 days median2020: 30 days median2022: 261 days median2025: 31 days median
2007high 261 (2022) · low 30 (2015)2026

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

Recalls per year · DRE

1in 2016

2009: 22010: 22011: 12015: 12016: 12026 (partial year): 1, 1 Class I
2007high 2 (2009) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DRE

356in 2025

2007: 812008: 382009: 692010: 732011: 902012: 1322013: 1202014: 822015: 822016: 842017: 1012018: 1262019: 1442020: 1202021: 1152022: 1362023: 3862024: 3252025: 356
2007high 386 (2023) · low 38 (2008)2025

MAUDE reports naming product code DRE, 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
20075160081
20082—038
20092—269
20101—273
20111—190
20121—0132
201341110120
2014672082
2015430182
2016390184
201741080101
20182—0126
20193680144
20203300120
20211—0115
202232610136
20232—0386
20241—0325
20253310356
20261—1 (1)—

What is it indicated for?

The TightRail Mechanical Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters and foreign objects.

Indications for use as stated in the FDA summary.

Also cleared against K061000

2 other devices cite the same predicate.

  • K142301Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath…Cook Vascular, Inc. · 2014
  • K141148Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath…Cook Vascular, Inc. · 2014

More from Spectranetics Corp.

183 FDA decisions under this applicant name. See the company

  • P910001/S127Philips Laser SystemSpectranetics Corp. · 2026
  • P910001/S126ELCA Coronary Laser Atherectomy CathetersSpectranetics Corp. · 2026
  • P910001/S124ELCA Coronary Atherectomy CathetersSpectranetics Corp. · 2026
  • P910001/S125ELCA Coronary Atherectomy CathetersSpectranetics Corp. · 2025
  • P050018/S035AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic CoatingSpectranetics Corp. · 2025

Recent decisions in DRE

The DRE category page

  • K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc. · 2026
  • K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L. · 2025
  • K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2025
  • K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc. · 2025
  • K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2024

https://510kreport.com/device/K140047 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140047: Lexiconture Mechanical Dilator Sheath Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140047

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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