510(k) Report

FDA applicant

Spectranetics (Philips)

Colorado Springs1 decision1997–19972 recalls

FDA records 1 decision for Spectranetics (Philips) (Colorado Springs) in 1997: 1 original PMA approval. All are in product code MFA (Device, Removal, Pacemaker Electrode…). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Spectranetics (Philips)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spectranetics (Philips) since 2007.

Recalls per year

1in 2012

2009: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Spectranetics (Philips) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MFADevice, Removal, Pacemaker Electrode, Percutaneous1decision

What has FDA decided for it lately?

  • P960042Spectranetics CVX-300 Excimer Laser System & Laser SheathSpectranetics (Philips) · 19972 recalls

The one decision as Spectranetics (Philips) →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P96004212Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to…Mar 13, 2012
  • P960042Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter…Mar 16, 2009

Other applicant names beginning “Spectranetics”

FDA records each applicant name separately; these may or may not be the same firm.

Spectranetics Corp. 48