ODY · Class II · 21 CFR 880.5970

FDA Product Code ODY: Tunneled Catheter Remover

To Assist In The Removal Of Tunneled Long Term Catheter Cuffs Using A Minimal Invasive Technique By Seperating The Tissue Ingrowth Cuff From The Surrounding Tissue. Following Seperation Of The Cuff From The Tissue, The Catheter Can Be Safely Removed From The Body.

Leading manufacturers include Tran Pa-C, Inc. and Symmetry Medical.

2
Total
2
Cleared
204d
Avg days
2007
Since

FDA 510(k) Cleared Tunneled Catheter Remover Devices (Product Code ODY)

2 devices
1–2 of 2
Cleared Sep 28, 2012
14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
K122263
Symmetry Medical
General Hospital · 63d
Cleared Sep 14, 2007
TRANS-CATHETER EXTRACTOR
K063048
Tran Pa-C, Inc.
General Hospital · 345d

About Product Code ODY - Regulatory Context