510(k) · Cleared
ClearedArrow 5FX60CM Balloon Embolectomy Catheter, Model # EM-56025
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DXE Catheter, Embolectomy
Cleared on Aug 31, 1998 as substantially equivalent to K892410 (Baxter Healthcare Corp, 1989) after a 75-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 31, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K892410 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK892410 Fogarty (R) Thru-Lumen Embolectomy CatheterBaxter Healthcare Corp · 1989 · Recalled
- This deviceK982141 Arrow 5FX60CM Balloon Embolectomy Catheter, Model # EM-56025Arrow Intl., Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892410 | Fogarty (R) Thru-Lumen Embolectomy Catheter | Baxter Healthcare Corp | 1989 | 1 |
| 0 (this device) | K982141 | Arrow 5FX60CM Balloon Embolectomy Catheter, Model # EM-56025 | Arrow Intl., Inc. | 1998 | — |
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 |
|---|---|---|---|
| * | K892410 | Fogarty (R) Thru-Lumen Embolectomy CatheterSummary page 1…123, a pre-amendment device. (Arrow Balloon Wedge Pressure Catheter) 2. Baxter 4 Fr Fogarty® Thru-Lumen Embolectomy Catheter, 12TLW804F, Premarket notification number: K892410. (Baxter Catheter) Description of device: The proposed device is identical to the legally marketed Arrow Single-Lumen 5F x 60… | 1989 |
| * | — | Arrow 5 Fr Balloon Wedge Pressure Catheter 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K892410.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Arrow Balloon Embolectomy Catheter is indicated for use as an accessory to the Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device. It is intended to be used to remove the arterial plug from the arterial anastamosis of a thrombosed hemodialysis access graft.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982141 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982141: Arrow 5FX60CM Balloon Embolectomy Catheter, Model # EM-56025.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982141
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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