PMA · Approved
Recalled · 2008Navi-Star Diagnostic/Ablation Deflectable Tip Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Approved on Jun 15, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 388-day review. It has been recalled once.
- Decided
- Jun 15, 2000
- Review
- 388 days
- Class
- Class II
- Product code
- DRF
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P990025 has 72 supplements since 2000: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 2 |
| 2006 | 4 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 4 |
| 2010 | 3 |
| 2011 | 4 |
| 2012 | 3 |
| 2013 | 6 |
| 2014 | 4 |
| 2015 | 5 |
| 2016 | 2 |
| 2017 | 6 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 7 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRF? 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2008 | Not classified | Z-0369-2010 | Process control | Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board (PCB) components used in the NaviStar RMT Catheters, which may cause the ablation catheter icon to shift on the map viewer when… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P990025 · printed Nov 6, 2026
Cite this page
510(k) Report. “P990025: Navi-Star Diagnostic/Ablation Deflectable Tip Catheter.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P990025
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026