Home / 510(k) Clearances / K190078

510(k) K190078

IntraSight by Volcano Corporation — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2019
Date Received
January 16, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

Other clearances by Volcano Corporation

  • K210235 — Verrata PLUS Pressure Guide Wire (April 15, 2021)
  • K203719 — IntraSight Mobile (January 19, 2021)
  • K202543 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, (September 28, 2020)
  • K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, (March 26, 2020)
  • K190626 — SyncVision System (April 12, 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)

Other clearances for product code DSA

  • K254114 — Baylis Connector Cable (January 18, 2026)
  • K252827 — IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abb (December 1, 2025)
  • K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, (September 30, 2025)
  • K242986 — SpO2 Extension Cable (May 2, 2025)
  • K243545 — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 98980 (January 17, 2025)
  • K240087 — RT Carbon ECG Leads (September 13, 2024)
  • K240377 — LIFEPAK® ECG Cables (May 7, 2024)
  • K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack (April 30, 2024)
  • K222712 — Fogg System Patient Monitoring Cables (November 22, 2023)
  • K230571 — RFP-100A Connector Cable (Single Use) (May 30, 2023)