Rotating Hemostatic Valve

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K911678 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Guiding Catheter (Tip Softness Change)

  Class II

  FDA 510(k) K883981 Active Cleared 3 Nov 1988

• Guiding Catheters 9F JL4

  Class II

  FDA 510(k) K871021 Active Cleared 16 Jun 1987

• Hollow Motor Drive Unit W/ Torque Controller

  Class II

  FDA 510(k) K920707 Active Cleared 23 Nov 1992

• Modified Simpson Peripheral Atherocath

  Class II

  FDA 510(k) K874706 Active Cleared 4 Jan 1988

• Rotating Hemostatic Valve

  Class II

  FDA 510(k) K883916 Active Cleared 28 Oct 1988

• Simpson Peripheral Atherocath W/Addit. Size 13F

  Class II

  FDA 510(k) K883346 Active Cleared 26 Sep 1988

See all devices from Devices For Vascular Intervention, Inc. →