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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