510(k) · Cleared
ClearedVascutrak 2, Models: V14 and V18
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ymed, Inc. · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Sep 11, 2008 as substantially equivalent to K073025 (Thermopeutix, Inc. Dba Ymed, Inc., 2007) after a 27-day review. Its family tree reaches back 3 generations to 1997. 47 later devices descend from it.
- Decided
- Sep 11, 2008
- Review
- 27 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971010 (1997). 6 ancestors in all. 47 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK971010 Peripheral Transluminal Angioplasty CathetersCordis Corp. · 1997
- 2 generations backK063657 Vascutrak Pta Dilation CatheterYmed, Inc. · 2006
- 1 generation backK073025 Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc. · 2007
- This deviceK082343 Vascutrak 2, Models: V14 and V18Ymed, Inc. · 2008
- Descendant · cites it directly · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
- Descendant · cites it directly · 32 of its ownK100303 Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy…Angioscore, Inc. · 2010
- Descendant · 2 generations on · 30 of its ownK110767 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- Descendant · 2 generations on · 29 of its ownK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- Descendant · 2 generations on · 29 of its ownK101735 Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-XxyyAngioscore, Inc. · 2010
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · cites it directly36descendants
- K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc. · 2010 · cites it directly32descendants
- K110767Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 2 generations on30descendants
- K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 2 generations on29descendants
- K101735Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-XxyyAngioscore, Inc. · 2010 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971010 | Peripheral Transluminal Angioplasty Catheters | Cordis Corp. | 1997 | — |
| −2 | K063657 | Vascutrak Pta Dilation Catheter | Ymed, Inc. | 2006 | — |
| −1 | K073025 | Vascutrak II Pta Dilatation Catheter | Thermopeutix, Inc. Dba Ymed, Inc. | 2007 | — |
| 0 (this device) | K082343 | Vascutrak 2, Models: V14 and V18 | Ymed, Inc. | 2008 | — |
| +1 | K103459 | Vascutrak Pta Dilatation Catheter | C.R. Bard, Inc. | 2010 | — |
| +1 | K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy… | Angioscore, Inc. | 2010 | — |
| +2 | K110767 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| +2 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| +2 | K101735 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-Xxyy | Angioscore, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 PNO? 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 PNO device
- #1 K261778 JADE SCORE PTA Scoring Balloon Dilatation…score 14.1 · 8 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 |
|---|---|---|---|
| * | K073025 | Vascutrak II Pta Dilatation CatheterSummary page 4…gths up to 120 mm. Modified Device Description The YMed VascuTraK™ 2 PTA Dilatation Catheter is a modification to the VascuTraK™ 2 PTA Dilatation Catheter cleared under K073025. The device is fabricated of the same materials as the unmodified device and has the same intended use. The distal balloon size… | 2007 |
What descends from it? (47)
See all 477 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103459 | Vascutrak Pta Dilatation Catheter | 2010 | 36 |
| K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-Xxyy | 2010 | 32 |
| K111738 | Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018) | 2011 | 5 |
| K120677 | Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014) | 2012 | 4 |
| K112281 | Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX | 2011 | 4 |
| K121402 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon… | 2012 | 3 |
| K122070 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon… | 2012 | 2 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K103459 (C.R. Bard, Inc., 2010) has gone furthest, with 36 descendants of its own.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · PNO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNO
246in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNO
No recall names PNO since 2007.
Adverse event reports per year · PNO
511in 2025
MAUDE reports naming product code PNO, 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 | 3 | 61 | 0 | 0 |
| 2008 | 4 | 28 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 23 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 84 | 0 | 0 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 3 | 74 | 0 | 26 |
| 2018 | 0 | — | 0 | 55 |
| 2019 | 1 | — | 0 | 81 |
| 2020 | 4 | 94 | 0 | 121 |
| 2021 | 1 | — | 0 | 90 |
| 2022 | 2 | — | 0 | 75 |
| 2023 | 0 | — | 0 | 304 |
| 2024 | 4 | 246 | 0 | 537 |
| 2025 | 2 | — | 0 | 511 |
| 2026 | 3 | 110 | 0 | — |
What is it indicated for?
The VascuTraK™ 2 PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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/K082343 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082343: Vascutrak 2, Models: V14 and V18.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082343
Report an extraction error
Are you the manufacturer?
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