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 Jun 18, 1997 as substantially equivalent to K944016 (Cardiovascular Dynamics, Inc., 1994) and 2 other predicates after a 58-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jun 18, 1997
- Review
- 58 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 deviceK971577 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) | K971577 | 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 Catheter 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?
FOCUS™-PV Balloon Dilatation Catheters-are tecommended foi-percutaneous transluminal angioplasty of the large vessels of the renal, femoral, popliteal, tibial, peroneal, iliac and profunda arteries and for treatment of obstructive lesions of native or synthetic arterovenous 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/K971577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971577: Focus-PV Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971577
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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