510(k) Report

510(k) · Cleared

Cleared

D-Clot Thrombectomy Catheter System, Model: DC 4006

K083370510(k) SpecialCleared Dec 12, 200828-day reviewClass II21 CFR 870.5150

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

Artegraft, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration

Cleared on Dec 12, 2008 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Dec 12, 2008
Review
28 days
Class
Class II
Product code
QEW
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K083370Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QEW? 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 QEW device

  1. #1 K213402 Triever24, Triever20score 28.6 · 5 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All QEW devices

QEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · QEW

14in 2025

2008: 22009: 22012: 12013: 22014: 22015: 42016: 42017: 22018: 142019: 82020: 162021: 112022: 122023: 232024: 142025: 142026 (partial year): 10
2007high 23 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEW

58in 2025

2015: 88 days median2016: 63 days median2018: 61 days median2019: 51 days median2020: 105 days median2021: 60 days median2022: 140 days median2023: 102 days median2024: 65 days median2025: 58 days median2026 (partial year): 74 days median
2007high 140 (2022) · low 51 (2019)2026

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

Recalls per year · QEW

7in 2022

2022: 7, 7 Class I
2007high 7 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · QEW

207in 2025

2019: 332020: 1972021: 3222022: 1252023: 1652024: 1622025: 207
2007high 322 (2021) · low 0 (2007)2025

MAUDE reports naming product code QEW, 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
20082—00
20092—00
20100—00
20110—00
20121—00
20132—00
20142—00
201548800
201646300
20172—00
2018146100
2019851033
2020161050197
202111600322
2022121407 (7)125
2023231020165
202414650162
202514580207
202610740—

What is it indicated for?

For breaking apart and removing thrombus from hemodialysis access grafts.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in QEW

The QEW category page

  • K262904INDIGO® Aspiration SystemPenumbra, Inc. · 2026
  • K253419Triever Duo CatheterInari Medical, Inc. · 2026
  • K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026
  • K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc. · 2026
  • K261523Vertex™ Thrombectomy SystemJupiter Endovascular · 2026

https://510kreport.com/device/K083370 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083370: D-Clot Thrombectomy Catheter System, Model: DC 4006.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083370

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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