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510(k) K212725

ViperCross Support Catheters by Cardiovascular Systems, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2021
Date Received
August 27, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • K203008 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Periphera (November 19, 2020)
  • 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)
  • K182397 — Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (December 13, 2018)

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