510(k) · Cleared
ClearedPeripheral Transluminal Angioplasty Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jun 18, 1997 after a 90-day review. The FDA summary names its predicate without a number. 93 later devices descend from it.
- Decided
- Jun 18, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
93 later devices descend from it, 9 citing it directly.
- This deviceK971010 Peripheral Transluminal Angioplasty CathetersCordis Corp. · 1997
- Descendant · cites it directly · 52 of its ownK063657 Vascutrak Pta Dilation CatheterYmed, Inc. · 2006
- Descendant · 2 generations on · 48 of its ownK073025 Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc. · 2007
- Descendant · 3 generations on · 47 of its ownK082343 Vascutrak 2, Models: V14 and V18Ymed, Inc. · 2008
- Descendant · cites it directly · 38 of its ownK050629 Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005
- Descendant · cites it directly · 37 of its ownK072225 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · Recalled
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K063657Vascutrak Pta Dilation CatheterYmed, Inc. · 2006 · cites it directly52descendants
- K073025Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc. · 2007 · 2 generations on48descendants
- K082343Vascutrak 2, Models: V14 and V18Ymed, Inc. · 2008 · 3 generations on47descendants
- K050629Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005 · cites it directly38descendants
- K072225Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · cites it directly37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971010 | Peripheral Transluminal Angioplasty Catheters | Cordis Corp. | 1997 | — |
| +1 | K063657 | Vascutrak Pta Dilation Catheter | Ymed, Inc. | 2006 | — |
| +2 | K073025 | Vascutrak II Pta Dilatation Catheter | Thermopeutix, Inc. Dba Ymed, Inc. | 2007 | — |
| +3 | K082343 | Vascutrak 2, Models: V14 and V18 | Ymed, Inc. | 2008 | — |
| +1 | K050629 | Angiosculpt Scoring Balloon Catheter | Angioscore, Inc. | 2005 | — |
| +1 | K072225 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2007 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 9 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 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 LIT? 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? (3)
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 |
|---|---|---|---|
| * | — | Savvy PTA Catheters Named without a submission number | |
| * | — | Opta 5 PTA Catheters Named without a submission number | |
| * | — | Ultra Thin PTA Catheter Named without a submission number |
What descends from it? (93)
See all 939 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063657 | Vascutrak Pta Dilation Catheter | 2006 | 52 |
| K050629 | Angiosculpt Scoring Balloon Catheter | 2005 | 38 |
| K072225 | Angiosculpt Pta Scoring Balloon Catheter | 2007 | 37 |
| K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 | 2008 | 36 |
| K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-Xxyy | 2010 | 32 |
| K021898 | Smart Control Nitinol Stent Transhepatic Biliary System | 2002 | 24 |
| K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation Catheter | 2014 | 6 |
| K201246 | PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) | 2021 | 0 |
| K083139 | Vipersphere Pta Balloon Catheter | 2008 | 0 |
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?
- Of its descendants, K063657 (Ymed, Inc., 2006) has gone furthest, with 52 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 Cordis PTA Catheters are intended for balloon dilatation of lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat 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/K971010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971010: Peripheral Transluminal Angioplasty Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971010
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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