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510(k) K233976

VasoGuard (V10, V8, V6, V4, V2) by Corvascular Diagnostics, LLC — Product Code JOP

K233976 is an FDA 510(k) premarket notification submitted by Corvascular Diagnostics, LLC for the device "VasoGuard (V10, V8, V6, V4, V2)". The FDA issued a decision of Substantially Equivalent on July 19, 2024. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2024
Date Received
December 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic
Device Class
Class II
Regulation Number
870.2880
Review Panel
CV
Submission Type

Other clearances for product code JOP

  • K242662 — Falcon/Xpress (Falcon/Xpress) (December 18, 2024)
  • K153762 — Smartdop XT6 (May 25, 2016)
  • K131623 — SMARTDOP XT (January 17, 2014)
  • K131860 — VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING (September 27, 2013)
  • K111416 — FALCON (July 15, 2011)
  • K071730 — STUDIODOP VICORDER (December 20, 2007)
  • K010482 — ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (March 20, 2001)
  • K002766 — NICOLET VASOGUARD (November 30, 2000)
  • K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER (September 16, 1999)
  • K925078 — SPECTRADOP (July 17, 1995)

FDA data resources