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Spectranetics, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories3
Latest FDA decision2022-12-15
TypeNumberDevice NameCodeDateActions
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)DRE2022-12-15 View
510(k) K222837 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersMCW2022-12-08 View
510(k) K212784 TightRail Guardian Motorized Dilator SheathDRE2022-08-24 View
510(k) K203540 Bridge Occlusion BalloonMJN2020-12-23 View
510(k) K180694 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersMCW2018-04-05 View
510(k) K172687 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersMCW2017-11-27 View
510(k) K170059 Spectranetics Turbo-Elite Laser Atherectomy CathetersMCW2017-04-07 View
510(k) K162561 Turbo-Power (2.0mm) Laser Atherectomy CathetersMCW2017-01-05 View
510(k) K161333 TightRail Sub-C Rotating Dilator SheathDRE2016-07-08 View
510(k) K153530 Bridge Occlusion BalloonMJN2016-02-05 View
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