510(k) Report

510(k) · Cleared

Cleared

AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter

K200206510(k) SpecialCleared Feb 27, 202030-day reviewClass II21 CFR 870.1250

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

Stryker Neurovascular · QJP Catheter, Percutaneous, Neurovasculature

Cleared on Feb 27, 2020 as substantially equivalent to K190833 (Stryker Neurovascular, 2019) after a 30-day review. Its family tree reaches back 9 generations to 2001. 1 later device descends from it.

Decided
Feb 27, 2020
Review
30 days
Class
Class II
Product code
QJP
Recalls
None
Predicates
1

Its longest line of descent runs back 9 generations to K003880 (2001). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.

  1. Root · 9 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
  2. 5 generations between
  3. 3 generations backK180715 React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
  4. 2 generations backK183463 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal…Stryker · 2019
  5. 1 generation backK190833 AXS Vecta Aspiration CatheterStryker Neurovascular · 2019
  6. This deviceK200206 AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular · 2020
  7. Descendant · cites it directly · 0 of its ownK241768 Broadway 8 CatheterStryker Neurovascular · 2024
Show all 9 generations
  1. Root · 9 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
  2. 8 generations backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
  3. 7 generations backK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
  4. 6 generations backK110483 Modified HD Guide CatheterConcentric Medical, Inc. · 2011 · Recalled
  5. 5 generations backK133177 Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · Recalled
  6. 4 generations backK151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal…Stryker · 2015 · Recalled
  7. 3 generations backK180715 React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
  8. 2 generations backK183463 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal…Stryker · 2019
  9. 1 generation backK190833 AXS Vecta Aspiration CatheterStryker Neurovascular · 2019
  10. This deviceK200206 AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K241768Broadway 8 CatheterStryker Neurovascular · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K003880Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022…Concentric Medical, Inc.2001—
−8K080583Modified HD Guide CatheterConcentric Medical, Inc.2008—
−7K090335HD Guide CatheterConcentric Medical, Inc.2009—
−6K110483Modified HD Guide CatheterConcentric Medical, Inc.20111
−5K133177Modified HD Guide CatheterConcentric Medical, Inc.20143
−4K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access…Stryker20153
−3K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2018—
−2K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access…Stryker2019—
−1K190833AXS Vecta Aspiration CatheterStryker Neurovascular2019—
0 (this device)K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular2020—
+1K241768Broadway 8 CatheterStryker Neurovascular2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
201010
201110
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K200206, 2001–2024Source: 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 QJP? 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 QJP device

  1. #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 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
*K190833AXS Vecta Aspiration Catheter
Summary page 5
…510(k) Manufacturer Number AXS Vecta Intermediate Stryker K190833 Catheter Neurovascular Device Description The AXS Vecta Intermediate Catheter is a single…
Stryker Neurovascular2019—
†K191768AXS Vecta Aspiration SystemStryker Neurovascular2019—

Also cleared against K190833: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K241768Broadway 8 CatheterStryker Neurovascular20240

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 19 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
  • 6 of the 14 ancestors have a recall of any class.
  • Of its descendants, K241768 (Stryker Neurovascular, 2024) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K190833.

How does its category compare?

All QJP devices

QJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · QJP

22so far in 2026, the most since 2007

2020: 92021: 122022: 142023: 142024: 182025: 142026 (partial year): 22
2007high 22 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJP

116in 2025

2020: 72 days median2021: 139 days median2022: 206 days median2023: 184 days median2024: 188 days median2025: 116 days median2026 (partial year): 141 days median
2007high 206 (2022) · low 72 (2020)2026

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

Recalls per year · QJP

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QJP

688in 2025

2020: 162021: 292022: 302023: 752024: 1302025: 688
2007high 688 (2025) · low 0 (2007)2025

MAUDE reports naming product code QJP, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
2020972016
202112139029
202214206030
202314184075
2024181881130
2025141160688
2026221410—

What is it indicated for?

The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K200206: AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200206

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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