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510(k) K190634

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2019
Date Received
March 12, 2019
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 Cardiovascular Systems, Inc.

  • K220109 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Periphera (March 1, 2022)
  • K212725 — ViperCross Support Catheters (September 24, 2021)
  • K210586 — Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Or (September 14, 2021)
  • K211240 — ViperCross Support Catheters (August 26, 2021)
  • K211251 — ViperCath XC Peripheral Exchange Catheter (May 26, 2021)
  • K210282 — WIRION Embolic Protection System (March 3, 2021)
  • K203008 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Periphera (November 19, 2020)
  • K200198 — WIRION (March 18, 2020)
  • K183000 — ViperCath XC Peripheral Exchange Catheter (December 29, 2018)
  • K182397 — Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (December 13, 2018)

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)