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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 5 of 5 Results
ProductCode: MCW Applicant: Spectranetics, Inc. Decision Date To: 06/01/2024
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turbo-power (2.0mm) laser atherectomy catheters, turbo-power (2.3mm) laser atherectomy catheters Spectranetics, Inc. K180694 04/05/2018
turbo-power (2.0mm) laser atherectomy catheters, turbo-power (2.3mm) laser atherectomy catheters Spectranetics, Inc. K172687 11/27/2017
spectranetics turbo-elite laser atherectomy catheters Spectranetics, Inc. K170059 04/07/2017
turbo-power (2.0mm) laser atherectomy catheters SPECTRANETICS, INC. K162561 01/05/2017
turbo-power laser atherectomy catheter SPECTRANETICS, INC. K152181 11/12/2015
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