510(k) · Cleared
ClearedCvsi Peripheral Balloon Catheter; Cvsi Catheter Inflation Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryo Vascular Systems, Inc. · DQY Catheter, Percutaneous
Cleared on Feb 19, 2003 as substantially equivalent to K022061 (Cryo Vascular Systems, Inc., 2002) and 1 other predicate after a 127-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Feb 19, 2003
- Review
- 127 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904275 (1991). 6 ancestors in all, the oldest K896849 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK904275 Morse Balloon Inflation DeviceNorth American Instrument Corp. · 1991
- 2 generations backK953676 Breeze Digital Inflation DeviceNamic · 1996
- 1 generation backK022061 Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002
- This deviceK023463 Cvsi Peripheral Balloon Catheter; Cvsi Catheter Inflation UnitCryo Vascular Systems, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904275 | Morse Balloon Inflation Device | North American Instrument Corp. | 1991 | — |
| −2 | K953676 | Breeze Digital Inflation Device | Namic | 1996 | — |
| −1 | K022061 | Cvsi Peripheral Balloon Catheter; Cvsi Inflater | Cryo Vascular Systems, Inc. | 2002 | — |
| 0 (this device) | K023463 | Cvsi Peripheral Balloon Catheter; Cvsi Catheter Inflation Unit | Cryo Vascular Systems, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K022061 | Cvsi Peripheral Balloon Catheter; Cvsi Inflater | 2002 |
| * | K971448 | Cordis Opta LP Pta Balloon CatheterSummary page 1…ICATE DEVICES (1) CVSi Peripheral Balloon Catheter System; CryoVascular Systems, hic. (KO2206 1) (2) OPTA LP PTA Catheter; Cordis/A Johnson & Johnson Company (K971448) INTENDED USE The CVSPM Peripheral Balloon Catheter and the CVSiTMCatheter Inflation Unit are indicated for percutaneous, trans… | 1997 |
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 12 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K022061.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CVSiTM Peripheral Balloon Catheter and the CVSiTM Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the superficial femoral and popliteal arteries. The CVSiTM Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSiTM Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023463: Cvsi Peripheral Balloon Catheter; Cvsi Catheter Inflation Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023463
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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