Home / 510(k) Clearances / K140775

510(k) K140775

TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM by Spectranetics Corporation — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2014
Date Received
March 28, 2014
Clearance Type
Traditional
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 Corporation

  • K133631 — LEXIPLIANT DILATOR SHEATH SET (March 27, 2014)

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)