510(k) · Cleared
ClearedVipersphere Pta Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Systems, Inc. · DQY Catheter, Percutaneous
Cleared on Nov 25, 2008 as substantially equivalent to K993913 (Infinity Extrusion & Engineering, Inc., 2000) and 3 other predicates after a 33-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Nov 25, 2008
- Review
- 33 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K001134 (2000). 7 ancestors in all, the oldest K971010 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 3 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 2 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 1 generation backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- This deviceK083139 Vipersphere Pta Balloon CatheterCardiovascular Systems, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −3 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −2 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −1 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| 0 (this device) | K083139 | Vipersphere Pta Balloon Catheter | Cardiovascular Systems, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K993913 | TRUESummary page 1…l Angioplasty Balloon Catheter Classification Name: Percutaneous Catheter (21 CFR 870.1250; Product Code: LIT) Predicate Device: 510(k) Number: K993913 Manufacturer: Infinity Extrusion & Engineering Trade Nam… | 2000 |
| * | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxSummary page 1…nfinity Extrusion & Engineering Trade Name: TRUE PTA Balloon Catheter 510(k) Number: K053116 Manufacturer: Boston Scientific Trade Name:… | 2005 |
| * | K971010 | Peripheral Transluminal Angioplasty CathetersSummary page 1…Boston Scientific Trade Name: Sterling PTA Balloon Catheter 510(k) Number: K971010 Manufacturer: Cordis Corporation Trade Name:… | 1997 |
| * | K052791 | Modification to: Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 1…Cordis Corporation Trade Name: Savvy PTA Balloon Catheter 510(k) Number: K052791 Manufacturer: ev3 Trade Name: Amphirion PTA… | 2005 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The ViperSphere PTA balloon dilatation catheter is intended to dilate stenoses in peripheral arteries including the iliac, femoral, popliteal, and infra-popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083139 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083139: Vipersphere Pta Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083139
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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