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Spectranetics, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories4
Latest Approval2022-12-15
TypeNumberDevice NameCodeDate
510(k) K223472 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) DRE 2022-12-15 View
510(k) K222837 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters MCW 2022-12-08 View
510(k) K212784 TightRail Guardian Motorized Dilator Sheath DRE 2022-08-24 View
510(k) DEN210024 CavaClear Laser Sheath QRJ 2021-12-21 View
510(k) K203540 Bridge Occlusion Balloon MJN 2020-12-23 View
510(k) K180694 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters MCW 2018-04-05 View
510(k) K172687 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters MCW 2017-11-27 View
510(k) K170059 Spectranetics Turbo-Elite Laser Atherectomy Catheters MCW 2017-04-07 View
510(k) K162561 Turbo-Power (2.0mm) Laser Atherectomy Catheters MCW 2017-01-05 View
510(k) K161333 TightRail Sub-C Rotating Dilator Sheath DRE 2016-07-08 View
510(k) K153530 Bridge Occlusion Balloon MJN 2016-02-05 View
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