Mardis Dangler Ureteral Stent Set

• • Terminated Z-1342-2009 FDA Unclassified (pre-2012) ·initiated 18 Mar 2009

  Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.

510(k) Number

K860267 ↗

FDA Product Code

FAD

Device Class

Class II

Regulation

21 CFR Part 876.4620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Van-Tec, Inc. →