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FDA 510(k) Applications Submitted by Spectranetics Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K223472
11/17/2022
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)
Spectranetics Inc.
K222837
09/20/2022
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Spectranetics Inc.
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