Jetstream Xc 2.4/3.4; Jetstream Xc 2.1/3.0; Jetstream Sc 1.85; Jetstream Sc 1.6

• • Terminated Z-1922-2017 FDA Class II ·initiated 5 Apr 2017

  Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREAM XC catheters may have been labeled as 1.85mm catheters.

510(k) Number

K133023 ↗

FDA Product Code

MCW

Models / Variants

Jetstream Xc 2.4/3.4

Jetstream Xc 2.1/3.0

Jetstream Sc 1.85

Jetstream Sc 1.6

Device Class

Class II

Regulation

21 CFR Part 870.4875

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Mriinnervu Disposable Endorectal Cervic Coil, Catalog No. Bcr-15

  Class II

  FDA 510(k) K952235 Active Cleared 26 Jun 1995

• Medrad Phased Array 1.5T Shoulder Imaging Surface Coil

  Class II

  FDA 510(k) K960901 Active Cleared 29 May 1996

• Benzalkonium-Heparin Coated Guidewires

  Class II

  FDA 510(k) K802473 Active Cleared 12 Nov 1980

• Medrad Counterpoise System

  Class II

  FDA 510(k) K944983 Active Cleared 29 Nov 1994

• Medrad Fluoroscopic Video Enhancement System

  Class II

  FDA 510(k) K884317 Active Cleared 20 Dec 1988

• Mrinnervu Endorectal Prostate Coil

  Class II

  FDA 510(k) K925029 Active Cleared 19 May 1993

See all devices from Medrad, Inc. →