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Spectranetics, Inc. FDA Approvals
0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)510(k)Dec 15, 2022Cardiovascular |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters510(k)Dec 8, 2022Cardiovascular |
| TightRail Guardian Motorized Dilator Sheath510(k)Aug 24, 2022Cardiovascular |
| CavaClear Laser Sheath510(k)Dec 21, 2021Cardiovascular |