PMA · Approved
Recalled · 2012Spectranetics CVX-300 Excimer Laser System & Laser Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics (Philips) · MFA Device, Removal, Pacemaker Electrode, Percutaneous
Approved on Dec 9, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 378-day review. It has been recalled 2 times.
- Decided
- Dec 9, 1997
- Review
- 378 days
- Class
- Class III
- Product code
- MFA
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P960042 has 67 supplements since 1998: 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 |
|---|---|
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2006 | 1 |
| 2009 | 4 |
| 2010 | 5 |
| 2011 | 7 |
| 2012 | 13 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 5 |
| 2018 | 6 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 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 MFA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|---|
| Mar 13, 2012 | Not classified | Z-1395-2012 | Nonconforming Material/Component | Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket. |
| Mar 16, 2009 | Not classified | Z-1264-2009 | Process control | Catheter outer jacket may split during use. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MFA devicesMFA Device, Removal, Pacemaker Electrode, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MFA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MFA
Too few MFA 510(k)s in any year since 2007 to give a median.
Recalls per year · MFA
No recall names MFA since 2007.
Adverse event reports per year · MFA
67in 2025
MAUDE reports naming product code MFA, 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 | 0 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 25 |
| 2009 | 4 | — | 0 | 46 |
| 2010 | 5 | — | 0 | 79 |
| 2011 | 7 | — | 0 | 80 |
| 2012 | 13 | — | 0 | 134 |
| 2013 | 2 | — | 0 | 142 |
| 2014 | 4 | — | 0 | 121 |
| 2015 | 2 | — | 0 | 73 |
| 2016 | 2 | — | 0 | 91 |
| 2017 | 5 | — | 0 | 96 |
| 2018 | 6 | — | 0 | 77 |
| 2019 | 3 | — | 0 | 66 |
| 2020 | 1 | — | 0 | 77 |
| 2021 | 1 | — | 0 | 83 |
| 2022 | 0 | — | 0 | 60 |
| 2023 | 1 | — | 0 | 55 |
| 2024 | 1 | — | 0 | 70 |
| 2025 | 1 | — | 0 | 67 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P960042 · printed Nov 6, 2026
Cite this page
510(k) Report. “P960042: Spectranetics CVX-300 Excimer Laser System & Laser Sheath.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960042
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026