Home / 510(k) Clearances / K192886

510(k) K192886

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip by Volcano Corporation — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2020
Date Received
October 10, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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  • K190626 — SyncVision System (April 12, 2019)
  • K190078 — IntraSight (February 11, 2019)
  • K173860 — s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultr (April 11, 2018)
  • K172455 — CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4. (October 25, 2017)
  • K172574 — SyncVision System (October 5, 2017)
  • K170385 — CORE M2 Vascular System (April 6, 2017)
  • K160583 — REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip (October 26, 2016)

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