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510(k) K222837

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters by Spectranetics, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2022
Date Received
September 20, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

Other clearances by Spectranetics, Inc.

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  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
  • DEN210024 — CavaClear Laser Sheath (December 21, 2021)
  • K203540 — Bridge Occlusion Balloon (December 23, 2020)
  • K180694 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Ather (April 5, 2018)
  • K172687 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Ather (November 27, 2017)
  • K170059 — Spectranetics Turbo-Elite Laser Atherectomy Catheters (April 7, 2017)
  • K162561 — Turbo-Power (2.0mm) Laser Atherectomy Catheters (January 5, 2017)
  • K161333 — TightRail Sub-C Rotating Dilator Sheath (July 8, 2016)

Other clearances for product code MCW

  • K250723 — FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Con (April 25, 2025)
  • K250385 — Turbo-Elite Laser Atherectomy Catheter (March 13, 2025)
  • K242757 — Rotarex Atherectomy System (January 30, 2025)
  • K242947 — FreedomFlow™ Orbital Circumferential Atherectomy System (November 5, 2024)
  • K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophili (June 27, 2024)
  • K233483 — FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Confi (February 15, 2024)
  • K233668 — Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Aury (December 15, 2023)
  • K231538 — FreedomFlow Orbital Circumferential Atherectomy System (September 27, 2023)
  • K230709 — Auryon Atherectomy System (June 9, 2023)
  • K230005 — Pantheris LV Atherectomy Catheter (June 6, 2023)