510(k) · Cleared
ClearedPeripheral Atherectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intensive Technology, Inc. · DWX Stripper, Artery, Intraluminal
Cleared on May 23, 1989 after a 111-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 36 devices in its family, counting itself, have a Class I recall. 35 later devices descend from it.
- Decided
- May 23, 1989
- Review
- 111 days
- Class
- Class II
- Product code
- DWX
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 1 citing it directly. 3 of the 36 devices in this family, counting this one, have a Class I recall.
- This deviceK890515 Peripheral Atherectomy SystemIntensive Technology, Inc. · 1989
- Descendant · cites it directly · 34 of its ownK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- Descendant · 2 generations on · 33 of its ownK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- Descendant · 2 generations on · 32 of its ownK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
- Descendant · 2 generations on · 28 of its ownK083489 Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc. · 2009
- Descendant · 3 generations on · 28 of its ownK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 35 · See all- K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008 · cites it directly34descendants
- K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008 · 2 generations on33descendants
- K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008 · 2 generations on32descendants
- K083489Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc. · 2009 · 2 generations on28descendants
- K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc. · 2009 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890515 | Peripheral Atherectomy System | Intensive Technology, Inc. | 1989 | — |
| +1 | K081328 | Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| +2 | K082186 | Modification to Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| +2 | K082664 | Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 | Pathway Medical Technologies, Inc. | 2008 | — |
| +2 | K083489 | Jetstream Pathway PC Atherectomy System, Model OV10300 | Pathway Medical Technologies, Inc. | 2009 | — |
| +3 | K083837 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 1 |
| 2019 | 1 | 0 |
| 2021 | 4 | 1 |
| 2025 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081328 | Pathway PV Atherectomy System | 2008 | 34 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K081328 (Pathway Medical Technologies, Inc., 2008) has gone furthest, with 34 descendants of its own.
How does its category compare?
All DWX devicesDWX Stripper, Artery, Intraluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWX
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · DWX
Too few DWX 510(k)s in any year since 2007 to give a median.
Recalls per year · DWX
No recall names DWX since 2007.
Adverse event reports per year · DWX
1in 2021
MAUDE reports naming product code DWX, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K890515 · printed Nov 5, 2026
Cite this page
510(k) Report. “K890515: Peripheral Atherectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K890515
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026