510(k) · Cleared
ClearedFocus PV Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Dynamics, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Mar 28, 1997 as substantially equivalent to K944016 (Cardiovascular Dynamics, Inc., 1994) and 2 other predicates after a 193-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Mar 28, 1997
- Review
- 193 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K944016 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK944016 Focus Balloon Dilatation CatheterCardiovascular Dynamics, Inc. · 1994
- This deviceK963688 Focus PV Balloon Dilatation CatheterCardiovascular Dynamics, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944016 | Focus Balloon Dilatation Catheter | Cardiovascular Dynamics, Inc. | 1994 | — |
| 0 (this device) | K963688 | Focus PV Balloon Dilatation Catheter | Cardiovascular Dynamics, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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.
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? (7)
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 |
|---|---|---|---|
| * | K944016 | Focus Balloon Dilatation CatheterSummary page 1…sique™ Balloon Dilatation Catheter Medi-tech Ultra-Thin™ Balloon Dilatation Catheter Medi-tech FOCUS™ Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K944016 SE Date: December 20,1994 FOCUS™ Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K952064 SE Date: June 21, 1… | 1994 |
| * | K952064 | Focus Balloon Dilatation CatheterSummary page 1…on Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K944016 SE Date: December 20,1994 FOCUS™ Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K952064 SE Date: June 21, 1995 FOCUS™ Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K954313 SE Date: December 1, 1… | 1995 |
| * | K954313 | Focus PC Balloon Dilatation CatheterSummary page 1…lloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K952064 SE Date: June 21, 1995 FOCUS™ Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K954313 SE Date: December 1, 1995 Page 6 CardioVascular Dynamics, Inc. FOCUS™-PV Balloon Dilatation Catheter 510(k) Not… | 1995 |
| * | — | Match 35™ PTA Balloon Catheters Named without a submission number | |
| * | — | Total Cross™ Balloon Dilatation Catheter Named without a submission number | |
| * | — | MS Classique™ Balloon Dilatation Catheter Named without a submission number | |
| * | — | Ultra-Thin™ Balloon Dilatation Catheter Named without a submission number |
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?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K944016.
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 FOCUS™-PV Balloon Dilatation Catheter is a balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.
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/K963688 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963688: Focus PV Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963688
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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