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510(k) K150262

Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular by Volcano Corporation — Product Code DTK

K150262 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular". The FDA issued a decision of Substantially Equivalent on April 3, 2015. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. Volcano Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2015
Date Received
February 4, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Intravascular, Cardiovascular
Device Class
Class II
Regulation Number
870.3375
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)
  • 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)

Other clearances for product code DTK

  • K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E) (September 10, 2024)
  • K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter (July 31, 2024)
  • K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK (June 26, 2024)
  • K240257 — Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (February 29, 2024)
  • K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM- (January 18, 2024)
  • K211875 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect (July 28, 2021)
  • K211874 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (July 28, 2021)
  • K181202 — Sentry IVC Filter (June 6, 2018)
  • K173236 — Sentry IVC Filter (February 22, 2018)
  • K172584 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (November 20, 2017)

FDA data resources