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510(k) K122987

STEALTH 360 ORBITAL PAD SYSTEM by Cardiovascular Systems, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2012
Date Received
September 26, 2012
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

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  • K200198 — WIRION (March 18, 2020)
  • K190634 — Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Or (July 2, 2019)
  • K183000 — ViperCath XC Peripheral Exchange Catheter (December 29, 2018)

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  • 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)