510(k) · Cleared
ClearedFogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences · DXE Catheter, Embolectomy
Cleared on May 20, 2024 as substantially equivalent to K901625 (Baxter Healthcare Corp, 1990) and 1 other predicate after a 189-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 20, 2024
- Review
- 189 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K901625 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK901625 Fogarty Arterial Embolectomy II CatheterBaxter Healthcare Corp · 1990 · Recalled
- This deviceK233619 Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards Lifesciences · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901625 | Fogarty Arterial Embolectomy II Catheter | Baxter Healthcare Corp | 1990 | 1 |
| 0 (this device) | K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | Edwards Lifesciences | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
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 DXE? 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 DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K901625 | Fogarty Arterial Embolectomy II CatheterSummary page 5…21 CFR 870.5150; Embolectomy catheter Regulation Name Product Code DXE Regulation Class II Fogarty Arterial Embolectomy II Catheters (K901625, cleared on July 06, 1990) Predicate Device Intramed® Graft Thrombectomy Instrument Set (K942457, cleared on February 07,… | 1990 |
| * | K942457 | Graft Thrombectomy InstrumentsSummary page 5…ss II Fogarty Arterial Embolectomy II Catheters (K901625, cleared on July 06, 1990) Predicate Device Intramed® Graft Thrombectomy Instrument Set (K942457, cleared on February 07, 1995) Fogarty Corkscrew Catheters: The Fogarty… | 1995 |
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.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K901625.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Fogarty Corkscrew Catheter is indicated for use in adult patients with emboli/thrombi in the peripheral arterial vasculature in either native vessels or synthetic grafts. The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for the removal of organized thrombus and adherent non‐thrombotic material from synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis access and synthetic grafts for…
Read the full statement (112 words)
The Fogarty Corkscrew Catheter is indicated for use in adult patients with emboli/thrombi in the peripheral arterial vasculature in either native vessels or synthetic grafts.
The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for the removal of organized thrombus and adherent non‐thrombotic material from synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis access and synthetic grafts for ileo‐femoral bypass in the peripheral arterial vasculature. General indications for arterial reconstruction of an obstructed graft include disabling claudication, ischemic pain at rest, or ischemic skin lesions or gangrene. General indications for reconstruction of a synthetic AV fistula internal bridge graft include the inability to properly dialyse the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233619: Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233619
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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