Catheter, Balloon Type

FDA product code GBA · Class I (low risk) · 21 CFR 878.4200 · General, Plastic Surgery

5510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K861877Byron Word Bartholian Gland CatheterGBA · Traditional Byron Medical05/30/1986SE
K802025Balloon Retention Chest CatheterGBA · Traditional Loseff Medical Designers, Ltd.09/26/1980SE
K790444Elecath Multi-Purpose Arterial SurgerGBA · Traditional Electro-Catheter Corp.06/11/1979SE
K781772Catheter, Transluminal BalloonGBA · Traditional Medi-Tech, Inc.03/06/1979SE
K781665Tube, Leatherman/ImbruceGBA · Traditional National Catheter Co. Div. Mallinckrodt12/15/1978SE

Recalls

RecallProductFirmInitiated
Z-1728-2013 Class II27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter…Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging… Karl Storz Endoscopy America Inc05/31/2013Terminated