Cathscanner Visions Microrail Ultra Imag Cath

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K924980 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600

  Class II

  FDA 510(k) K911384 Active Cleared 25 Jun 1991

• Visions 8.2F Pv Ultrasonic Imaging Catheter (Model 88900)

  Class II

  FDA 510(k) K982329 Active Cleared 14 Jan 1999

• Endosonics Trak Back Device

  Class II

  FDA 510(k) K990271 Active Cleared 30 Aug 1999

• Cathscanner II Intravascular Ultrasonic Imaging Sy

  Class II

  FDA 510(k) K926252 Active Cleared 25 Oct 1993

• Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700

  Class II

  FDA 510(k) K000820 Active Cleared 5 Jun 2000

• Precept-Pt(Tm) Microsensor Pressure Monitor Cath.

  Class II

  FDA 510(k) K890492 Active Cleared 2 Mar 1989

See all devices from Endosonics Corp. →