510(k) · Cleared
Recalled · Class I · 2013Radius Ptca Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radius Medical Technologies, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on May 20, 1997 after a 102-day review. The FDA summary names its predicate without a number. 8 of the 50 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- May 20, 1997
- Review
- 102 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 2 (2 Class I)
- Predicates
- 0
49 later devices descend from it, 5 citing it directly. 8 of the 50 devices in this family, counting this one, have a Class I recall.
- This deviceK970466 Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997
- Descendant · cites it directly · 36 of its ownK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- Descendant · cites it directly · 32 of its ownK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- Descendant · 2 generations on · 31 of its ownK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- Descendant · 3 generations on · 16 of its ownK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
- Descendant · cites it directly · 10 of its ownK091582 GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular · 2009 · Recalled (Class I)
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 49 · See all- K021441Radius SnareRadius Medical Technologies, Inc. · 2002 · cites it directly36descendants
- K022201Radius Micro SnareRadius Medical Technologies, Inc. · 2003 · cites it directly32descendants
- K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003 · 2 generations on31descendants
- K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps · 2008 · 3 generations on16descendants
- K091582GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular · 2009 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970466 | Radius Ptca Guidewire | Radius Medical Technologies, Inc. | 1997 | — |
| +1 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| +1 | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| +2 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| +3 | K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | William Cook Europe Aps | 2008 | — |
| +1 | K091582 | GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15 | Medtronic Vascular | 2009 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2004 | 1 | 1 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 1 |
| 2009 | 2 | 1 |
| 2010 | 2 | 2 |
| 2011 | 2 | 1 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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.
8 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.
Top candidate predicates for a new LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | ACS High Torque Guidewire family Named without a submission number |
What descends from it? (49)
See all 495 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2013 | Class I | Z-0267-2014 | Nonconforming Material/Component | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. |
| Oct 21, 2013 | Class I | Z-0263-2014 | Nonconforming Material/Component | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. |
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.
- K091582GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K032899Radius Cougar WireRadius Medical Technologies, Inc. · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 12 Class I recalls
- K100470GTX 12 GidewireMedtronic, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- Of its descendants, K021441 (Radius Medical Technologies, Inc., 2002) has gone furthest, with 36 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
The Radius PTCA Guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA.
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/K970466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970466: Radius Ptca Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970466
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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