510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Vascon Neuropath Guiding Catheter

K052004510(k) TraditionalCleared Jan 19, 2006178-day reviewClass II21 CFR 870.1250Recalls 24

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

Vascon, LLC · DQY Catheter, Percutaneous

Cleared on Jan 19, 2006 after a 178-day review. The FDA summary names its predicate without a number. It has been recalled 24 times.

Decided
Jan 19, 2006
Review
178 days
Class
Class II
Product code
DQY
Recalls
24
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K052004Source: FDA 510(k) database · 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
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What was it cleared against? (2)

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
*—Cordis Guiding Catheter (ENVOY® series)
Named without a submission number
—
*—VasCon Guiding Catheter (Polaris™)
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 11, 2013Class IIZ-0845-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0848-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0860-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0865-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0844-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0846-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0850-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0851-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0852-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0854-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0859-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0861-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0862-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0864-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0843-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0847-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0853-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0856-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0857-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0858-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0863-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0842-2013Component design/selectionSterility of device may be compromised due to lack of packaging integrity
Jan 11, 2013Class IIZ-0849-2013Component design/selectionSterility of device may be compromised due to lack of package integrity
Jan 11, 2013Class IIZ-0855-2013Component design/selectionSterility of device may be compromised due to lack of package integrity

The 5 latest of 24 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

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?

VasCon NeuroPath TM Guiding Catheter is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices.

Indications for use as stated in the FDA summary.

More from Vascon, LLC

4 FDA decisions under this applicant name. See the company

  • K053310Vascon Roamer MicrocatheterVascon, LLC · 2008
  • K043387Vascon Polaris Guiding CatheterVascon, LLC · 2005
  • K033633Vascon Polaris Guiding CatheterVascon, LLC · 2004

Recent decisions in DQY

The DQY category page

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  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
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https://510kreport.com/device/K052004 · printed Nov 3, 2026

Cite this page

510(k) Report. “K052004: Vascon Neuropath Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K052004

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026