510(k) Report

510(k) · Cleared

Cleared

Stand & High Flow Femoral-Ventricular Pigtail Cath

K862006510(k) TraditionalCleared Jun 27, 198631-day reviewClass II21 CFR 870.1200

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

Cordis Corp. · DQO Catheter, Intravascular, Diagnostic

Cleared on Jun 27, 1986 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Jun 27, 1986
Review
31 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2005: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK862006 Stand & High Flow Femoral-Ventricular Pigtail CathCordis Corp. · 1986
  2. Descendant · cites it directly · 2 of its ownK051561 Asahi Angiographic CatheterAsahi Intecc Co., Ltd. · 2005
  3. Descendant · 2 generations on · 1 of its ownK082559 Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2008
  4. Descendant · 3 generations on · 0 of its ownK090913 Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2009
  5. Descendant · cites it directly · 0 of its ownK970469 Evt Angioscale Angiographic CatheterGuidant Cardiac and Vascular Surgery · 1997

Most influential descendants

Showing 4 of 4 · See all
  • K051561Asahi Angiographic CatheterAsahi Intecc Co., Ltd. · 2005 · cites it directly2descendants
  • K082559Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2008 · 2 generations on1descendant
  • K090913Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2009 · 3 generations on0descendants
  • K970469Evt Angioscale Angiographic CatheterGuidant Cardiac and Vascular Surgery · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862006Stand & High Flow Femoral-Ventricular Pigtail CathCordis Corp.1986—
+1K051561Asahi Angiographic CatheterAsahi Intecc Co., Ltd.2005—
+2K082559Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.2008—
+3K090913Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.2009—
+1K970469Evt Angioscale Angiographic CatheterGuidant Cardiac and Vascular Surgery1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200510
200810
200910
FIG. 1 — Lineage of K862006, 1986–2009Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQO? 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K051561Asahi Angiographic CatheterAsahi Intecc Co., Ltd.20052
K970469Evt Angioscale Angiographic CatheterGuidant Cardiac and Vascular Surgery19970

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?

  • Of its descendants, K051561 (Asahi Intecc Co., Ltd., 2005) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

More from Cordis Corp.

551 FDA decisions under this applicant name. See the company

  • P020026/S086Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2014
  • K130981Flexstent Biliary Self Expanding Stent System; S.M.a.R.T. RE-Flex Biliary Elf-Expanding Stent SystemCordis Corp. · 2014
  • K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
  • P020026/S082Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012
  • P020026/S085Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K862006 · printed Nov 6, 2026

Cite this page

510(k) Report. “K862006: Stand & High Flow Femoral-Ventricular Pigtail Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862006

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026