510(k) Report

510(k) · Cleared

Cleared

4F Nylex Angiography Catheter/5F Nylex Angiography Catheter

K971646510(k) TraditionalCleared Jul 14, 199770-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 Jul 14, 1997 as substantially equivalent to K962759 (Cordis Corp., 1996) and 2 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided
Jul 14, 1997
Review
70 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K930479 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors2018: 1 descendant clearedK930479 · Nylex Catheters · Cordis Corp. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K930479 · Nylex Catheters · Cordis Corp. · 19930
  1. Root · 1 generation backK930479 Nylex CathetersCordis Corp. · 1993
  2. This deviceK971646 4F Nylex Angiography Catheter/5F Nylex Angiography CatheterCordis Corp. · 1997
  3. Descendant · cites it directly · 0 of its ownK181836 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography…Cordis, A Cardinal Health Company · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K1818364F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo…Cordis, A Cardinal Health Company · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930479Nylex CathetersCordis Corp.1993—
0 (this device)K9716464F Nylex Angiography Catheter/5F Nylex Angiography CatheterCordis Corp.1997—
+1K1818364F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F &…Cordis, A Cardinal Health Company2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K971646, 1993–2018Source: 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 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? (3)

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
*K9627594F Nylex Angiographic Catheter
Summary page 1
…ry Name: Cordis 4 F Nylex™ Angiography Catheter and Cordis 5 F Nylex™ Angiography Catheter Name of Predicate Devices Cordis Corporation 4 F Nylex™ Angiography Catheter (K962759) Cordis Corporation 5 F Nylex™ Angiography Catheter (K930479) Cordis Corporation Envoy™ and Vista Brite Tip™ Guiding Catheter (K…
Cordis Corp.1996—
*K930479Nylex Catheters
Summary page 1
…Nylex™ Angiography Catheter Name of Predicate Devices Cordis Corporation 4 F Nylex™ Angiography Catheter (K962759) Cordis Corporation 5 F Nylex™ Angiography Catheter (K930479) Cordis Corporation Envoy™ and Vista Brite Tip™ Guiding Catheter (K962362) Classification Class Il Performance Standards Perfor…
Cordis Corp.1993—
*K962362Cordis Envoy & Vista Brite Tip Guiding Catheters
Summary page 1
…4 F Nylex™ Angiography Catheter (K962759) Cordis Corporation 5 F Nylex™ Angiography Catheter (K930479) Cordis Corporation Envoy™ and Vista Brite Tip™ Guiding Catheter (K962362) Classification Class Il Performance Standards Performance standards have not been established by the FDA under section 514 of…
Cordis Corp.1996—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K1818364F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo…Cordis, A Cardinal Health Company20180

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K181836 (Cordis, A Cardinal Health Company, 2018) has gone furthest, with 0 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)—

What is it indicated for?

Cordis Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K971646 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971646: 4F Nylex Angiography Catheter/5F Nylex Angiography Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971646

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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